Semantic search
| Start date | Report date | Site | Reporting criterion | System | Event description | |
|---|---|---|---|---|---|---|
| ENS 56965 | 14 February 2024 16:10:00 | Trinity Health Of New England Medical Group - Ghc Nuclear | 10 CFR 35.3045(a)(3) | The following is a summary of information provided by the licensee via phone: At 1110 EST on February 14, 2024, a patient was administered the wrong radiopharmaceutical. The prescribed dose was 25 mCi Tc-99m pyrophosphate, and the administered dose was 25 mCi Tc-99m sestamibi. The patient and referring physician were informed. There were no adverse effects to the patient. The total effective dose equivalent for this study was estimated to be 1,200 mrem.
After further review, the dose to the patient was below reporting threshold. The radiopharmaceutical was a diagnostic tracer and non-therapeutic. Notified R1DO (Bickett), NMSS (Rivera-Capella), and NMSS Events (email). A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient | ||
| ENS 56758 | 21 September 2023 04:00:00 | Stamford Hospital | 10 CFR 35.3045(a)(3) | The following information is a summary of the information provided by the licensee via telephone: On September 21, 2023, a female patient received the first of three scheduled doses using a vaginal cylinder containing 5 curies of Iridium 192. The cylinder shifted inadvertently during the administration by about 3.5 centimeters outward causing the dose to the intended site to be different than the intended dose. The patient was informed. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 56638 | 24 July 2023 15:00:00 | Christiana Care Health System | 10 CFR 35.3045(a)(3) | The following is a summary of information provided by the licensee via telephone: A patient was prescribed Y-90 microsphere implants to the liver. The procedure occurred on 4/20/23 with no abnormal outcomes reported. The patient returned to the hospital on 7/24/23 reporting stomach pain which was diagnosed as an ulcer. A biopsy of the ulcer revealed microspheres. Due to the tissue damage, it was assessed that the dose to the stomach lining exceeded 50 Rem. This event is being reported per 10 CFR 35.3045(a)(3).
The following information was provided by the licensee via telephone: The Radiation Safety Officer called the NRC Headquarters Center at 1405 EDT to retract Event 56638. NRC and Christiana, the licensee, assessed the event, and determined that it was due to shunting, and thus did not meet the criteria of a medical event. Notified R1DO (Dimitriadis) and NMSS Events Notification (email) A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 56139 | 3 October 2022 16:10:00 | Henry Ford Hospital | 10 CFR 35.3045(a)(3) | The following information was provided by the licensee via phone: On 10/3/22, a medical event occurred when a written directive was incorrect. The nuclear medicine staff recognized the written directive was incorrect and delivered the correct dose to the proper location. The patient was not harmed. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 54822 | 5 August 2020 18:00:00 | Department Of Veterans Affairs | 10 CFR 35.3045(a)(3) | A Y-90 microsphere therapy administration was performed on August 5, 2020, (at VA Boston Healthcare System in Boston, Massachusetts). The prescribed dose was intended for the right lobe of the liver. Post implant imaging on that day indicated that the dosage of microspheres was unintentionally administered to a portion of the left lobe of the liver. The patient and the referring physician have been notified. The National Health Physics Program (NHPP) will follow up with a written report in accordance with NRC requirements in 10 CFR 35.3045. NHPP notified our NRC Region III Project Manager (Parker). A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 53814 | 3 January 2019 06:00:00 | Washington University In St. Louis | 10 CFR 35.3045(a)(3) | EN Revision Text: MEDICAL EVENT - Y-90 THERASPHERES ADMINISTERED TO THE WRONG LIVER SEGMENT A medical event occurred on 1/3/2019 at Washington University in St. Louis. The patient treatment plan called for 1.06 GBq of Y-90 TheraSpheres to be administered to Segments 6 and 7 of the patient's liver. However, 1.02 GBq of Y-90 TheraSpheres were administered to Segments 5 and 8 of the patient's liver instead. The patient and the referring physician were notified of the event. Washington University in St. Louis has initiated an investigation of the event.
The following was received via email from the licensee: As a follow up to the phone call placed today (1/14/19) at 12:56 pm EST, (the licensee radiation safety officer) is writing to retract the report of a event number 53814. The initial report of a suspected medical event with the administration of Y-90 microspheres to a patient was made on 1/4/19 at 12:15 pm EST. After taking the limitations of the imaging software into account, the reviewing team of clinicians have evaluated that the Y-90 microspheres were administered to the correct patient, with the correct dosage and correct route of administration, and in agreement with the Written Directive. Notified R3DO (PELKE) and NMSS vis email. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 53616 | 21 September 2018 05:00:00 | Missouri Baptist Medical Center | 10 CFR 35.3045(a)(3) | The patient's first dose of 110.3 microCuries, 4.3 mL, of Ra-223 (Xofigo) was administered today, 9/21/18 at 1040 CDT. An IV was placed by RN (Registered Nurse) in the patient's left wrist. The IV was flushed with saline and blood return was checked and present prior to administration of Ra-223 by (the) MD (medical doctor). The Ra-223 was delivered by MD. After delivery, the MD began (a) saline flush and after approximately 5cc of saline, noted resistance and a cold bulge near the infusion site. He was not able to get blood return. The RN was called in to check the IV and was not able to get blood return. It was noted an infiltration/extravasation had occurred. The IV was removed with catheter noted to be intact. Prior to the infusion the patient was told that the infusion should not be painful and he did not acknowledge any pain or discomfort during or after infusion. At this time it is not known if there was an extravasation of Ra-223 because the infiltration/extravasation was not noted until during the second saline flush. The patient and patient's family were notified at the time of the incident.
The licensee does not believe there was more than 10 percent of therapy dose that was not infiltrated. Based on the fact that the swelling went down in less than 45 minutes post imaging of the wrist, compared to the body, leads the Radiation Safety Officer (RSO) to believe most of the therapy dose went throughout the body. Notified R3DO (Orth) and NMSS vis email. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 52917 | 18 August 2017 19:00:00 | Washington University | 10 CFR 35.3045(a)(3) | A medical event occurred on 8/18/2017 when Y-90 TheraSpheres meant for treatment of the patient's left liver lobe were administered to the patient's right liver lobe. The patient treatment plan was for radioembolization of the left lobe of the liver on 8/18/17 and radioembolization of the right liver lobe approximately one month later. The interventional radiologist (IR) and radiation oncologist authorized user (AU) signed off on planning activity for the left lobe via the left hepatic artery on 8/2/17 and 8/3/17, respectively. The AU completed the 8/18/17 written directive to deliver 124 Gy to the left lobe via the left hepatic artery (LHA). The IR placed the catheter for treatment in the right hepatic artery which supplies the right liver lobe. The AU, medical physicist and radiation technologist came to the procedure room. A time out procedure was done asking all parties to confirm 124 Gy to the left lobe via the LHA. The IR gave a verbal affirmation of this plan. The IR discovered the error when reviewing patient notes following the procedure. He immediately notified the AU who then notified the Radiation Safety Officer (RSO). The AU estimated dose to the right lobe to be 63 Gy. The RSO continues investigating the event. The patient and the referring physician were notified of the medical event. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 52524 | 31 January 2017 15:51:00 | Henry Ford Hospital | 10 CFR 35.3045(a)(1) 10 CFR 35.3045(a)(3) | A patient at the Henry Ford Hospital Interventional Radiology Department was prescribed a Y-90 Theraspheres treatment of 60 Gray to the left lobe of the liver. The Interventional Radiologist administered 46 Gray total to both the right and the left lobe of the liver. The referring physician has been notified and the licensee has notified the patient. It is believed that this event will not result in any harm to the patient. The licensee is in the process of determining corrective action to prevent reoccurrence. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 50729 | 8 January 2015 15:00:00 | Elkhart General Hospital | 10 CFR 35.3045(a)(3) | A patient who was to be given a myocardial stress profusion exam was incorrectly given a 160 mCi dose of technetium pertechnetate (instead of prescribed Tc-99m sestamibi). The cause of the incident was the medical technologist deviated from established procedures. There is no expected adverse impact on the patient as a result. The patient and physician have been informed. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 50603 | 11 November 2014 05:00:00 | Parkview Health | 10 CFR 35.3045(a)(3) | A patient was prescribed four 550 cGy gynecologic brachytherapy treatments totaling 2200 cGy. The third treatment prescribed a treatment area of 5 cm instead of the actual treated area of 7 cm. The patient was released after the outpatient treatment. The hospital in attempting to notify the physician of the incident. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
Based on the results of an onsite inspection from NRC Region 3 Inspectors (Craffey and Lambert), it was determined that this event did not meet the regulatory report threshold and is being retracted by the licensee. Notified R3DO (Peterson) and NMSS Events Notification (email). | ||
| ENS 50369 | 10 July 2014 17:20:00 | Botsford Hospital | 10 CFR 35.3045(a)(3) | A patient undergoing High Dose Rate Brachytherapy using Ir-192 was prescribed 700 cGy per fraction and only received 700 cGy to 60% of the planned volume. The patient was scheduled for two treatments. The first treatment was successfully administered to the patient on 6/26/14. When the patient returned for the second treatment on 7/10/14 the HDR afterloader was loaded with the treatment plan for the original treatment instead of the second treatment. This resulted in the patient not receiving the full prescribed treatment. The licensee discovered the problem during an audit when the number of catheters did not match. There are no adverse health effects expected as a result of this treatment. The licensee has contacted the vender to determine a way to remove old treatment plans from the machine to ensure this does not happen in the future. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 48903 | 8 April 2013 14:30:00 | Mid Michigan Medical Center | 10 CFR 35.3045(a)(3) | On 04/08/13 at approximately 1030 EDT a female patient undergoing brachytherapy treatment for cervical/vaginal cancer received the first of three fractions. The prescribed dose for the first fraction was 400 cGy, however, the wrong length catheter was used. This placed the source 5 cm inferior to the intended treatment site. The actual dose received has not been determined at this time. This error was discovered on 04/09/13 during a review by the Medical Physicist. Both the prescribing physician and patient have been informed. There are no adverse health consequences anticipated due to this error in treatment. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 49182 | 20 December 2012 06:00:00 | St Alphonsus Regional Med Ctr | 10 CFR 35.3045(a)(3) | On December 20, 2012, a patient was administered microspheres to treat the liver. On July 9, 2013 the administering facility learned that a biopsy identified microspheres in a slow healing gastric ulcer. The facility is assuming that the patient received a dose that exceeded the limits based on the presence of microspheres and the development of a gastric ulcer.
Based on discussion with NRC Region 4 and after a review process, the licensee is retracting this report. Notified R4DO (Gaddy). A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 48195 | 15 August 2012 14:00:00 | Deaconess Hospital | 10 CFR 35.3045(a)(3) | A HDR (High Dose Rate) treatment was planned for a patient's mammary area, but the delivery of the source position was offset from the intended delivery. The patient and referring physician were informed of the difference between the planned and the delivered dosage. The patient will receive follow-up to discuss potential options. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 46470 | 9 December 2010 18:00:00 | Pipe County Memorial Hospital | 10 CFR 35.3045(a)(3) | A representative of the licensee (the hospital rad tech) reported that two patients were administered doses of diagnostic Technetium-99m (Tc-99m) for the wrong organs due to a mixed-up of the dose vials. Specifically: Patient #1 received a 25 millicurie Tc-99m dose for a bone scan instead of the prescribed 10 millicurie Tc-99m dose for a Hida scan (to the gall bladder). Shortly thereafter, Patient #2 received the 10 millicurie Tc-99m dose for a Hida scan instead of the prescribed 25 millicurie Tc-99m dose for a bone scan. Both errors were discovered when the actual diagnostic scans were performed. The patients, their physicians, and the RSO have been notified of this event. The licensee representative stated that there should be no harm to the patient from the incorrect administration. The cause of this event was reported to be insufficient verification that the proper vial had been selected for injection. Both vials were reported to be identical in appearance. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
After further review of the event described above, the licensee determined that the event was not reportable to the NRC Operations Center. The retraction is based on a determination that the dose to the organs involved did not exceed the reportability limits. The licensee will log the details of this event. R3DO (Daley) and FSME (Diaz-Torro) notified. | ||
| ENS 45250 | 6 August 2009 21:00:00 | Valley Hospital | 10 CFR 35.3045(a)(3) | A patient with radiation seed prostate implants came back to the facility to have a CAT Scan. Based on the CAT Scan results, the physician suspects the improper positioning of the radiation seed implants. Due to the patient's medical condition the hospital cannot conduct a verification CAT Scan with contrast material. The patient plans to return to the hospital at a later date. A hospital review of the patient's treatment is ongoing.
The licensee confirmed that the patient had improper positioning of the radiation seed implants. This was considered an under dose to the patient since the seeds went into the tissue and not the prostate. The patient was advised by the physician and will receive a follow-on treatment with a tomotheraphy procedure. Notified FSME (Andrew Mauer) and R1DO (William Cook). A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 45184 | 3 July 2009 00:00:00 | Gamma Knife Center Of The Pacific | 10 CFR 35.3045(a)(3) | A gamma knife treatment was prescribed for a patient being treated for multiple brain metastatic sites using an 8 mm collimator. The prescribed dose was 24 gray. The treatment was prescribed for 7 discrete sites in the brain. After the second discrete site had been treated it was found that an 18 mm collimator was being used to administer the treatment instead of the prescribed 8mm collimator. After discovery, the collimator was changed to the 8 mm collimator. Treatment to the remaining 5 discrete sites was administered with the 8 mm collimator. Both the patient and the patient's physician were notified of the use of the wrong collimator. The licensee states that there should be no clinical effects to the patient as a result of this misadministration. The previous patient had been treated using the 18 mm collimator as the prescribed collimator. Investigation into this event is continuing and a written report will follow. In an effort to prevent recurrence, the licensee will send a notice to all authorized users, neurosurgeons and medical physicists that they should each independently check collimator size before each treatment is started. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
The use of the 18 mm collimator instead of the 8 mm collimator increased the treatment site dose by 3%. The larger collimator caused the volume of each of the two treatment areas to increase by 2.35 cm3 (cubic centimeters). This additional tissue received a dose of 24 Gy. If the correct collimator had been used, this tissue would have received a dose of approximately 4.3 Gy. Both the physician and patient have been notified by the licensee. Notified the R4DO (Gaddy) and FSME (Reis). | ||
| ENS 44589 | 15 October 2008 18:00:00 | Saint Mary'S Medical Center | 10 CFR 35.3045(a)(3) | The patient was being treated for a thyroid condition with a capsule of I-131 (150 milliCi). The procedure involved the patient swallowing the capsule to position it near the thyroid. During the procedure the capsule became lodged in the patient's throat due to an esophageal obstruction. The staff attempted to aid in passing the capsule by having the patient drink soda and eat applesauce. The capsule eventually passed the obstruction after approximately 2 1/2 hours. The estimated dose to the esophagus was 1000 Rads. The calculated dose to the esophagus is 1786 Rads. The patient is following-up with a physician today and at that time will be notified of the overexposure. The potential adverse effects of this dose are esophagitis (inflammation of the lining of the esophagus) and radiation fibrosis. The licensee initially investigated this event shortly after it occurred and at the time contacted NRC R2 (Gabriel). At that time, based on the information that was available (mainly time the device was lodged in the patients esophagus), this event was deemed not reportable. When new information became available to the licensee the event was determined to be reportable. A Medical Event may indicate potential problems in a medical facilities use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 44021 | 27 February 2008 16:00:00 | Reid Hospital & Health Care Services | 10 CFR 35.3045(a)(3) | Sixty-two I-125 seeds were to be implanted in a patient's prostate. After 37 seeds were implanted, surgery was halted and the location verified as being 1-2 cm below the prostate. The hospital is evaluating the medical implications of this event. The physicians and patient were notified. Seeds: 0.315 milliCuries each
The NRC's medical events review committee has determined that is report is a medical event. A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 43082 | 8 January 2007 15:30:00 | Hackley Hospital | 10 CFR 35.3045(a)(1) 10 CFR 35.3045(a)(3) | During a seed implant procedure for treating prostate cancer with I-125 (41 seeds with 0.32 millicuries each), the patient moved after inserting 2 of the 14 treatment needles. The procedure was delayed for five minutes to allow the patient to be more completely under general anesthesia. The lineup was checked using ultrasound and once the urologist, the radiation oncologist, and the medical physicist were comfortable with the situation, the seed implant was resumed. Once the procedure was completed, the hospital personnel took a film shot to verify the needle placement. It was discovered that the 12 of 14 remaining needles that were inserted were not in the intended location. The patient has been notified of the error. The hospital is in the process of determining the prostate underdose and the overdose to the unintended areas (rectal and urethra). The hospital is still evaluating any patient intervention that needs to be identified and if there is any unintended permanent functional damage to other organs. A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 43685 | 31 August 2006 04:00:00 | Carilion Clinic | 10 CFR 35.3045(a)(3) | On August 31, 2006 a female patient received mammosite treatment for a breast lesion using a HDR with an Ir-192 source. The treatment consisted of placing a catheter into the treatment site, inflating a balloon with between 35-75 ml saline and positioning the Ir-192 source inside the catheter into the center volume of the saline balloon. This allows for a homogenous dose to the treatment site. While in the OR (Operating Room), the catheter was inserted and saline introduced through one of the two catheter connections to inflate the balloon. The patient was taken to the HDR location where the technologist inadvertently connected the HDR to the saline vice the HDR connector. This resulted in draining the saline balloon into the HDR unit. The technologist recognized that the HDR was improperly connected, broke the connection and reconnected to the proper port. When the prescribed 416 second treatment was commenced, the HDR automatically shutdown after 223 seconds retracting the Ir-192 source to the safe position. An evaluation by the licensee concluded that the incident was not reportable since it did not meet the criteria for an underdose. During an inspection conducted 7/26/07 (Inspection Report No. 2007-001), the NRC Inspector noted that since the saline balloon had been inadvertently drained tissue in a .5 cubic centimeter volume adjacent to the source received a significantly higher dose (approximately 20 Gray) than prescribed. In a follow-up call from NRC Region I on 10/03/07, the licensee was requested to notify the NRC Operations Center of this finding. The licensee informed the prescribing physician and the patient was also notified. No adverse effects to the patient have been noted. A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 43112 | 13 June 2006 17:00:00 | Surgical Center Of Central Florida | 10 CFR 35.3045(a)(3) | The State of Florida was notified on 01/11/07 by Florida Agency for Health Care Administration that while performing an audit of the licensee it appeared a misadministration of brachytherapy seeds on June 13, 2006 was not reported to DOH-BRC, nor was there any documentation it was done. The State is planning to visit the licensee in the next few days to obtain details of this medical event from the Radiation Oncologist. The auditor provide the following documentation to the State concerning a prostate seed implant procedure performed on June 13, 2006 at the Surgical Center of Central Florida: A review of preplanning, live planning and post planning documents was conducted on June 22, 2006, and a wrong site administration (as defined in Florida Administrative Code 64&5. 101, 88-6) was declared by the prescribing radiation oncologist and the Radiation Safety Officer associated with the Cancer Care Center of Sebring. Their conclusion was supported by diagnostic films and the physics calculations. Consistent with the Florida Radiation Safety Guidelines, the patient's referring physician was also contacted by the treating urologist on June 23, 2006 and (the) facility was advised within 24 hours of the finding. Both the patient and his wife have been informed of the post procedure evaluation results and the patient has undergone a diagnostic computed tomography exam and follow-up appointment at the Cancer Care Center in Sebring. As a result of further assessment, the apparent misadministration incident was determined to be reportable to the State of Florida pursuant to Florida Administrative Code Section 53E-5.345 4A by the license holder and its' Radiation Safety Officer. . . . The procedure involved the implant of sixty I-125 seeds totaling approximately 20 milliCuries. A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 42566 | 9 May 2006 18:00:00 | Bozeman Deaconess Hospital | 10 CFR 35.3045(a)(3) | A medical event was identified during the post-implant CT scan of a prostate implant patient. A total of 88 seeds were implanted (30.3 milliCuries total). The CT scan confirmed that most of the seeds were located in an area surrounding the urethra instead of the prostrate. The patient's physician has been informed. The licensee will continue to investigate this event. | ||
| ENS 42511 | 11 April 2006 15:40:00 | United Hospital Center | 10 CFR 35.3045(a)(3) | The RSO of the United Hospital Center called about a misadministration to 2 female patients being treated for cervical cancer. Each patient was to receive a total of 3000 centigrays, distributed via 6 treatments of 500 centigrays each. The treatment was a high dose rate Brachytherapy insertion of a 4.4 Curie Ir-192 sealed source into the cervical area. On their first treatment, patient #1 received 1040 centigrays at 11:40 EDT on 04/11/06, and patient #2 received 1058 centigrays at 11:45 EDT on 4/18/06. The attending physician is now going to alter the remaining treatments to 350 centigrays/treatment for each patient, thereby keeping the original total dose to the required 3000 centigrays/patient. The reason given for the misadministration was human error. The operator did not check the magnification reading on the computer before administrating the dose to each patient. The referring physician will be discussing this error with each patient when they come in for their next treatment on 4/21/06. | ||
| ENS 42474 | 8 November 2005 06:00:00 | Community Hospitals Of Indiana | 10 CFR 35.3045(a)(3) | Community Hospitals of Indiana reported that a high dose rate (HDR) remote afterloader treatment field was incorrectly performed. On November 8, 2005, Community Hospital East in Indianapolis, Indiana performed a HDR treatment on a terminally ill lung cancer patient. Community Hospital East applied the correct dose to the patient. However, a catheter used to carry the source into the patients body was inserted into the patients airway without a cap on the end. As a result of the cap not being in its proper place on the catheter, the source was placed approximately 7 mm higher than originally intended per the physicians written directive. As a result, the field which was irradiated was greater by approximately 7 mm. Immediately following the treatment, the error was noted and the physician was informed. The physician noted that the area which was irradiated was within her area of concern and that everything was "o.k." This treatment was conducted to relieve patient symptoms rather than cure the disease. The patient succumbed to the disease approximately two weeks later. The treatment and its results were documented by the licensee in its Radiation Safety Committee Meeting minutes. During a routine inspection of its records on 4/4/06, a Region III NRC Inspector noted that this event appeared to be a medical event and should be reported. As a result of that guidance, the licensee is reporting the event.
The licensee provided the doses for the above event. Due to the catheter cap not being in its proper place the airway area above the lung received an actual dose 500 rads, whereas the prescribed dose was to be 200 rads. The area of treatment in the lung received an actual dose 200 rads, whereas the prescribed dose was to be 500 rads. Notified R3DO (Anne-Marie Stone) and NMSS (Greg Morell) | ||
| ENS 42038 | 3 October 2005 04:00:00 | Department Of Veterans | 10 CFR 35.3045(a)(3) | l am calling per 10 CFR 35.3045 to notify you of a possible medical event at the VA Medical Center, Philadelphia, Pennsylvania. On October 3, 2005 a permanent implant prostate brachytherapy procedure was performed at the medical center. A written directive prescribed 90 Iodine 125 seeds to be implanted in the patient's prostate. However, 45 of the seeds were implanted mistakenly in bladder. The seeds were recovered from the bladder prior to completion of the procedure in the operating room. The written directive was revised by the authorized user prior to completion of the procedure in the operating room to document the actual number of seeds implanted in the prostate (45). Based on dosimetry calculations performed October 4, 2005, a medical event may have occurred since the dose to the prostate and other tissues may differ from that originally prescribed in the written directive by values greater than those given in 10 CFR 35.3045. These circumstances appear to be similar to a previously reported event (Event No. 39586), which NRC ultimately decided did not represent a medical event. However, the NHPP has decided conservatively to perform an on-site review at the medical center next week to assess the particular circumstances of this event. At the time of this report the licensee did not know why the event happened but will be investigating to determine the cause and the significance on 10/13/2005. The licensee stated that the patient was notified of the situation.
Based on our discussions with NRC Region III, the circumstances for event do not meet the definition in 10CFR35.3045 as a medical event. Contacted the R1DO (Meyer), R3DO (Riemer), and NMSS EO (Morell). | ||
| ENS 41361 | 26 January 2005 03:30:00 | University Of Minnesota | 10 CFR 35.3045(a)(1) 10 CFR 35.3045(a)(3) | A patient undergoing a 31 hour treatment plan for cervical cancer received less than the prescribed dose delivered to the treatment site and a higher than intended dose to other tissue(s)/organ(s), specifically: Treatment site A: planned 1643 centiGray, delivered 821 centiGray Treatment site B: planned 465 centiGray, delivered 372 centiGray Bladder: planned 1147 centiGray, delivered 1448 centiGray Rectum: planned 1147 centiGray, delivered 2012 centiGray Treatment was delivered from 1430 hours on 1/24 and 2130 hours on 1/25 using a low dose rate tandem brachytherapy device containing three Cs-137 sources; 14 milligram Ra-equiv, 9.8 milligram Ra-equiv and 9.8 milligram-equiv. There were two additional Cs-137 ovoid sources, each 14.1 milligram Ra-equiv. The tandem device has a rod that was cut 6 cm. short such that when the tandem was positioned in the patient, the three tandem sources were not extended the proper distance inside the tandem device. The ovoid sources were properly positioned. The referring physician and patient have been informed. The radiation staff oncologist does not believe that this medical event will have any adverse effect on the patient and a new treatment plan is being prepared for the patient. | ||
| ENS 42023 | 11 March 2004 06:00:00 | St.Vincent Hospital | 10 CFR 35.3045(a)(3) | As a result of a retrospective review of HDR brachytherapy cases, a medical event was discovered. This event occurred on March 11, 2004, which involved a single esophageal HDR brachytherapy treatment. In this case, a 62 year old female patient, was treated with a Nucletron High Dose Rate (HDR) brachytherapy remote afterloader for esophageal cancer . The physician Authorized User (AU) prescribed a dose of 500 cGy at 0.5 cm from the surface of a N/G tube (naso-gastric tube) for an active length of 8.0 cm using a 8.49 Curie Iridium-192 source. The treatment plan called for 17 indexer step positions at 5.0mm spacing to begin at dwell position 23 and terminating at dwell position 39. The medical physicist entered 17 indexer step positions with 5.0 mm spacing at dwell positions 1 through 17 and treatment was delivered. As the intended delivery site was to be delivered an intended dosage of 500 cGy for one fraction for a total of 500 cGy, the dose delivered to the unintended site was 500 cGy while the intended treatment site was not treated. This patient is now deceased. It is not believed this medical event was a significant contributing factor in the cause of death when consideration of the prognosis of the disease is given. Although this medical event occurred March 11, 2004, it was discovered 17:45 ET on September 27, 2005, as a result of a retrospective review. The licensee has notified Region 3 (Madera and Mulay) about this event. | ||
| ENS 40696 | 1 March 2004 05:00:00 | Missouri Baptist Medical Center | 10 CFR 35.3045(a)(3) | A female patient received a potential dose to the skin on the inner thigh during a High Dose Rate Treatment. The treatment occurred in late February to early March. This was discovered on 4/21/04, when the patient returned for follow-up and markings on the inner thigh were noticed that were unusual for the intended treatment area. The licensee is determining the actual exposure to the skin. The patient has been notified. | ||
| ENS 41532 | 23 February 2004 06:00:00 | St Joseph Regional Medical Center | 10 CFR 35.3045(a)(3) | The following information was supplied by the licensee: Two patients involved in what we now think to be reportable events. 1. A.M. 2-23-04 to 2-24-04 2. R.M. 3-01-04 to 3-02-04 In both cases the patients were being treated for endometrial cancer with brachytherapy. A new Wang vaginal applicator was used. The tandem was loaded with incorrect size sources (of Cs-137) which then had the ability to slide out of the intended treatment position through the placement spring when the patient would sit in a more up-right position. With the sources out of position they would irradiate the patients inner thigh. The dose to the thigh had to be estimated based on estimated time the patient was in an up-right position and the effect seen on the skin. At the time these incidents took place it was not felt that reportable events had taken place because of the calculated exposure to the thigh, patient symptoms, and the interpretation of 35.3045 (a) (1)(2), (3). One of the patients (A.M.) returned recently (1/05) with an ulcer at the area of thigh exposure. This has caused the radiation therapy staff to reevaluate their dose estimation to the patients. After review, it is believed that reportable events my have occurred based on 35.3045 (A) (3). This conclusion was formulated on 3-25-05 after a staff meeting and 1 received the final letter from the physician today 3-28-05. The tandem manufacturer recommends 3M seeds and the facility used Amersham seeds which resulted in the seeds shifting. A total of 5 patients were treated. The initial estimates determined that the exposure was less than the reportable limit. All the patients were notified of the exposure. One of the two overexposed patients is responding well to treatment. The other patient may have received the higher dose. The remaining three patients appear to have received less than the reportable dose.
Discussion between the licensee and NRC Region 3 inspectors determined that a third patient should be added to this event: 3. K.B. 3-19-04 to 3-22-04 Notified R3DO (Riemer) and NMSSEO (Collins).
Discussion between the licensee and NRC Region 3 inspectors determined that a fourth and fifth patient should be added to this event: 4. D. T. 1/26/04 to 1/27/04 5. M. S. 2/18/04 to 4/21/04 Notified R3DO (O'Brien) and NMSS EO (Leach). | ||
| ENS 39941 | 12 June 2003 04:00:00 | Guthrie Health Care | 10 CFR 35.3045(a)(1) 10 CFR 35.3045(a)(3) | A patient was referred for treatment, due to reoccurring prostate cancer, to the hospital where he had previously had treatment. Seeds were implanted around May 2001. A scan of the previous treatment of implanted seeds determined that many of the seeds were not located in the prostate, but in adjacent tissue where they would have been ineffective in treatment. Also, a review of the records indicated a scan was performed in early 2002, but was not followed up on. The patient and referring physician have been informed. The hospital is conducting an investigation into the event and also developing a plan to provide appropriate treatment for the patient.
Post-op dosimetry on one patient was determined to be a misadministration. The dose that covered the prostate was more than 20 percent different from the prescription as well as the penile bulb dose being close to 50 percent of the prescription dose. Efforts are being made to contact the affected patient. The licensee will continue efforts to obtain post-op dosimetry on the rest of the patients related to this incident so that evaluations for misadministration can be performed. Notified R1DO (Della Greca) and NMSS EO (Pierson).
Post-op dosimetry for two patients were determined to be a misadministration. The patients had their prostates treated some time in the year 2001. The iodine-125 seeds were placed 2 to 3 centimeters below the area where they were supposed to be located. The improper location of the iodine-125 seeds caused more than 50% of the prescribed dose to be delivered to an un-intended organ. The patients will be notified. Notified R1DO (Dan Holody) and NMSS EO (Trish Holahan).
Two additional patients of a group of seven were identified as having received a misadministration of iodine-125 to an unintended organ. The patients will be notified of this misadministration. The licensee is in the process of clarifying and document the issues related to this incident. Notified R1DO (James Moorman) and NMSS EO (Tom Essig).
Another patient has been identified who received a misadministration of iodine-125 to the prostate. The prescribed dose was 144 Gy, and it was delivered using 76 seeds and 27 needles as planned prior to the implant date. After reviewing the CT, which was done on Feb. 27, 2001, the V100 of the prostate received 29% of the prescribed dose. The penile bulb at 72 Gy received 44.8%. The licensee indicated that they have looked into 8 patients who may have been misadministered, of which, one was not declared a misadministration. The other seven appear in this notification. There are 23 total patients that the licensee intends to review. Notified R1DO (Clifford Anderson) and NMSS EO (Fred Brown).
Twelve more patients have been added to the number of patients. Patients are identified by a six digit number. Patient# (deleted)- On this date, March 21, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 77 seeds and 26 needles as planned prior to the implant, The V 100 of the prostate received 39% of the prescribed dose and the V50 of the penile bulb received 88%. Patient# (deleted)- On this date, May 23, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed close was delivered using 53 seeds and 18 needles as planned prior to the implant. The V100 of the prostate received 62% of the prescribed dose and the V50 of the penile bulb received 57%, Patient# (deleted)- On this date, December. 13, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 86 seeds and 21 needles as planned prior to the implant. The V 100 of the prostate received 70% of the prescribed dose and the V50 of the penile bulb received 99%. Patient# (deleted)- On this date, February 22, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 77 seeds and 25 needles as planned prior to the implant. The V100 of the prostate received 52.5% of the prescribed dose and the V50 of the penile bulb received 80%. Patient# (deleted)- On this date, March 15, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 67 seeds and 27 needles as planned prior to the implant. The V 100 of the prostate received 59% of the prescribed dose and the V50 of the penile bulb received 86.5%. Patient# (deleted)- On this date, July 5, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 62 seeds and 21 needles as planned prior to the implant. The VI 00 of the prostate received 49% of the prescribed dose. Patient# (deleted)- On this date, February 8, 2001, the former physician, prescribed a dose of 144-Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 45 seeds and 18 needles as planned prior to the implant. The V 100 of the prostate received 68% of the prescribed dose. Patient# (deleted)- On this date, September 5, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 58 seeds and 20 needles as planned prior to the implant. The V100 of the prostate received 59.5% of the prescribed dose. Patient# (deleted)- On this date, May 31, 2001, the former physician, prescribed a dose of 14-4Gy to the prostate using 1-125 seeds. The prescribed dose was delivered using 60 seeds and 17 needles as planned prior to the implant. The V1 00 of the prostate received 68% of the prescribed. Dose. Patient# (deleted)- On this date, January 22, 2001, the former physician, prescribed a dose of 144Gy to the prostate using I-125 seeds. The prescribed dose was delivered using 54 seeds and 3, 8 needles as planned prior to the implant. The V100 of the prostate received 73% of the prescribed dose, Patient# (deleted)- On this date, January 10, 2001, the former physician, prescribed a dose of 144Gy to the prostate using I-125 seeds. The prescribed dose was delivered using 58 seeds and 19 needles as planned prior to the implant. The VI 00 of the prostate received 54% of the prescribed dose. Patient# (deleted)- On this date, June 21, 2001, the former physician, prescribed a dose of 144Gy to the prostate using 1-125 seeds, The prescribed dose was delivered using 82 seeds 28 needles as planned prior to the implant, The V 100 of the prostate received 73% of the prescribed dose. Notified R1DO (Glenn Meyer) & NMSS EO (Linda Psyk).
Patient # (deleted) - On 10/3/2001, the former physician prescribed a dose of 144 Gy to the prostate using I-125 seeds. The dose was delivered using 67 seeds and 23 needles as planned prior to the implant. The V100 of the prostate received 72.5% of the prescribed dose. Patient # (deleted) - On 10/4/2001, the former physician prescribed a dose of 144 Gy to the prostate using I-125 seeds. The dose was delivered using 74 seeds and 30 needles as planned prior to the implant. The V100 of the prostate received 66.7% of the prescribed dose. Notified R1DO (Pam Henderson) and NMSS EO (Tom Essig) | ||
| ENS 39586 | 3 February 2003 05:00:00 | Philadelphia Va Medical Center | 10 CFR 35.3045(a)(3) | Informed by a representative of the Department of Veteran's Affairs National Health Physics Program (NHPP) that a possible medical event may have occurred at the Philadelphia Veterans Administration Medical Center. The event took place on February 3, 2003 but was not determined until it was discussed on February 13, 2003. The procedure being performed at the time of the event was a permanent prostate seed implant brachytherapy. The nuclide involved is I-125. A fraction of the seeds intended to be implanted into the prostate were recovered from the bladder. The medical authorized user (the physician prescribing and performing the procedure) rewrote the written directive in the operating room to reflect the number of seeds that were successfully implanted into the prostate. Calculations are presently being made to determine the exposure to the bladder. Preliminary calculations indicate that there are no deterministic effects to the patient as a result of the event. All the seeds are presently accounted for. There was no patient intervention. The NHPP is currently investigating the event.
Based on our discussions with NRC Region III, the circumstances for event do not meet the definition in 10CFR35.3045 as a medical event. Contacted the R1DO (Meyer), R3DO (Riemer), and NMSS EO (Morell). |