Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55006 | 23 November 2020 04:00:00 | Agreement State | Dosed Incorrect Organ | The following information was received from the state of New York via fax: A medical licensee reported on 11/23/2020 that a Y90 microsphere procedure performed on Friday 11/20/2020 was later discovered to have had the catheter connected to the gallbladder instead of the liver as prescribed in the written directive. More information will be forthcoming but preliminary information shows that the microspheres were Sirtex SIR-Spheres. New York Incident Number: NYDOH-20-07. 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 54398 | 20 November 2019 18:00:00 | Agreement State | Agreement State Report - Iodine 125 Seed Migrated from Implant Location | The following was received from the State of New York via fax: The New York State Department of Health (NYSDOH) was notified by a NYS medical licensee that they had an incident where an lodine-125 seed (200 microCi assayed on 11/12/2019) had migrated from the original implant location in the left breast of a female patient. According to the licensee, two seeds were implanted on 11/18/2019 for localization during an 11/20/2019 procedure. During this procedure on 11/20/2019, it was noticed by the surgeon that one of the seeds had migrated about 2 inches from its original implant location. The surgeon and radiologist concluded that any attempt to retrieve the seed in question would compromise patient care. The seed was not retrieved as a result. The facility contacted the New York State Department of Health two hours after the licensee determined that the lodine-125 localization seed could not be retrieved from the patient and will be submitting a written report within the required timeframe. DOH will continue to monitor this incident. New York State incident No.: 19-07 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 53017 | 21 September 2017 04:00:00 | Agreement State | Agreement State Report - Post Implant Loss of Iodine-125 Seed | The following information was received from the State of New York via facsimile: On September 21, 2017 the Department (New York State Department of Health) was notified that a Best Medical International, Inc., Model #2301 lodine-125 seed used for localization of non-palpable lesions and lymph nodes was lost. On September 18, a patient was implanted with a 125.2 microCurie lodine-125 seed. The seed was verified to be implanted by use of a survey meter. When the patient returned for explant three days later, the iodine-125 seed could not be detected. The licensee surveyed the patient's vehicle, house, laundry, and trash and no radioactivity was detected. The licensee reported placing the seed 'superficially' within the patient and the licensee speculates that the seed may have become dislodged from the patient at some point between the implant and explant. New York Report ID No.: NYDOH-NY-17-08 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | ||
| ENS 52697 | 12 April 2017 04:00:00 | Agreement State | Agreement State Report - Less than Intended Dose Administered to the Patient | The following information was provided by the State of New York via facsimile: On 04/12/2017, a patient with widespread neoplasm of liver, intrahepatic bile duct, received treatment with Y90 SIRTEX microspheres to 2 separate segments in the right lobe. The intended activities were 0.946 GBq (25.6 mCi) to a small segment and 2.38 GBq (64.3 mCi) to the large segment. On 4/18/17, during a review of the patient's medical record, the AU (authorized user) physician discovered that the activity ordered for the large lesion was 0.38 GBq, not 2.38 GBq, as the written directive had stated. NYS DOH (New York State Department of Health) was informed on 4/19/17. Both the patient and the referring physician have been informed. AU physician stated that there is no harm to the patient, because they plan to administer the deficit dose to this segment in the right lobe during the procedure scheduled to treat the left lobe next month. The licensee stated that documentation/communication appears to be the primary cause. Facility is investigating. Will update when more information becomes available. NY Event Report ID No. NYDOH-NY-17-07 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 52667 | 5 April 2017 04:00:00 | Agreement State | Agreement State Report - Less than Prescribed Dose Administered to Patient | The following information was provided by the State of New York via facsimile: On 04/05/2017, a patient with metastatic esophageal cancer received right hepatic lobar treatment (to the liver) with Y90 from SIRTEX microspheres. The intended activity was 32.9 mCi. Drawn activity was 32.7 mCi. The administered activity measured at the end of the procedure was 8.2 mCi (25 percent of intended activity). Probable cause stated by the licensee: 'clumping' of microspheres resulting in occlusion of vial 'delivery C' needle provided by the vendor. The licensee plans to (1) request review from the manufacturer of the preparation and handling of the microspheres prior to arrival to the IR suite, (2) Since the patient is already planned for a left lobar treatment, a whole liver treatment will be planned to deliver the deficit dose to the right lobe. NY Event Report ID No. NYDOH-NY-17-06 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 52593 | 4 March 2017 05:00:00 | Agreement State | Agreement State Report - Missing Iodine 125 Calibration Sources | The following information was provided by the State of New York via Facsimile: A New York Licensee's RSO (Radiation Safety Officer) left voice mail on March 5, Sunday afternoon, stating that he was informed on the evening of the previous day (March 4, 2017) that 2 vials containing 15 seeds of I-125 that were to be used for calibration purposes were missing from their inventory. The total activity of the 15 seeds was reported to be less than 7 mCi. The surface exposure rates at the exterior of the lead shielded vials was stated to be at background radiation levels. The AU (Authorizing User) physician and the RSO conducted a thorough search on March 5, 2017, but and were unable to locate the seeds. DOH will staff became aware of the event earlier this morning (March 6, 2017) on arrival at work. Will update after following up with the licensee. NY State Event Report ID NO. NYDOH-NY-17-05 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | ||
| ENS 52473 | 29 December 2016 05:00:00 | Agreement State | Agreement State Report - Medical Event | The following report was received via fax: We (New York State Department of Health) were informed on January 3, 2017 that on December 29, 2016, a 61 year old female patient was to receive SIR spheres Y90 infusion to 2 lesions in her liver at a hospital. The small lesion was to receive 10% and the large lesion was to receive 90% of 24.53 mCi Y90. Staff prepared 2 vials according to the Written Directive, and labeled each vial shield. When the first infusion, for the smaller lesion, was called for, a technologist took one vial to the IR room. She believed she had the correct 10% marked vial. She removed the top of the shielded container holding the vial, then she left the IR suite. The patient was injected. When the second infusion, for the large lesion, was called for, the same technologist took the second shielded vial from the hot lab and noticed that it was the one marked with the 10% label. It appears that the vials themselves were not labeled, only the lids of the containers holding the vials were labeled. Once they realized what had happened, they decided to infuse the second larger lesion with what was left over in the first vial as well as what was in the second vial. The licensee has not yet provided the values for the actual administered dose to each lesion. However, it appears clear that the discrepancy in the prescribed activity and administered activity for each lesion meets the reportable medical event criteria. (The licensee's) initial report stated there is no harm to the patient. A full report, including the actual activity delivered and a root cause analysis is required/pending. 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 52304 | 17 October 2016 04:00:00 | Agreement State | Agreement State Report - Medical Underdose | The following report was received via fax: Radiation Safety Staff from a hospital in New York called on 10/18/2016 to report that for a patient who was treated with SIR Spheres (containing Y-90) on 10/17/16, it was estimated that about 22.5% less than intended had been delivered. 4.05 mCi was ordered. Assayed at 4.2 mCi. Post treatment survey of the device and residuals showed 1.06 mCi left over. Which means 3.14 mCi was administered, instead of the intended 4.05 mCi. They will mail a report within a week. New York state Event #NYDOH-NY-16-07 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 51970 | 24 May 2016 04:00:00 | Agreement State | Agreement State Report - Medical Underdose to the Left Lobe of Liver | The following report was received from the New York State Department of Health, Bureau of Environmental Radiation Protection via facsimile: Radiation safety staff from a hospital called on 5/24/2016 to report a medical event that meets the reportability criterion on the borderline. 79.5 percent of intended dose is believed to have been delivered to the left lobe of the liver of a patient receiving Y90 treatment. The patient had received treatment to the right lobe a month ago. The left lobe was smaller with small vessels. The waste measured after the procedure showed that only about 79 .5 percent had been delivered. The licensee usually is able to administer 95 percent of intended dose in this procedure. We were informed that since the amount retained in the device is about the same, smaller doses tend to show a greater percent in retained in the device. They will send a report within 7 days. NYS NRC Event Report ID No.: NYDOH-16-02 NY State Incident No.: 1146 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 51919 | 2 December 2015 05:00:00 | Agreement State | Agreement State Report - Unplanned Contamination Event | The following information was received via E-mail: On May 11, 2016, the licensee's radiation safety officer reported an unplanned contamination event which occurred on December 2, 2015. The RSO stated he did not think this was a reportable event until his medical physicist instructed him to report the incident. During treatment of a patient, a radioactive capsule of I-131 was provided to a patient. The patient had problems swallowing the capsule. The patient eventually chewed the capsule and in the minutes following had an episode, expelling the capsule and other bodily fluids. The bodily fluid was collected in a bag, although some of the fluid dripped onto the floor. The droplets which fell on the floor were collected and placed in a collection bag. The floor was cleaned and the bag containing all the waste items was taken to nuclear medicine for decay prior to disposal. The area was covered with an adsorbent pad. Readings on the surface were 38 mR/hr and 1.8 mR/hr at one meter. A mobile lead wall/shield was put in place to restrict the area. Radiation caution signs were also placed in the area with a do not enter sign on the door leading to the room. The room remained restricted for more than 24 hours. On February 25, 2016 the area was released at background readings. As of March 25, 2016 the waste bag remains in storage awaiting disposal. The Agency (Texas Department of State Health Services) has withheld the name of the licensee in accordance with Texas state law. Texas Incident #: I-9401 | ||
| ENS 51390 | 10 September 2015 04:00:00 | Agreement State | Agreement State Report - Medical Treatment Dose Lower than Prescribed | The following was received from the State of New York via fax: A New York State licensee informed the Department (New York State Department of Rad Health) of a patient receiving HDR therapy being delivered a fractionated dose that differed from the prescribed fractionated dose by more than 50 percent. The written directive called for a vaginal treatment consisting of three fractions of 1050 cGy per fraction. The second of the three fractions was scheduled on September 10, 2015. Treatment began as planned with both the AU and the AMP at the console. After successful extension and retraction of the dummy source, it was noticed that treatment countdown time was increasing instead of decreasing. The source extension was in contradiction to the console, which indicated 'treatment terminated' although the source extension warning light was also activated near the console. Two AMPs engaged the Emergency-Stop, terminating the treatment and retracting the source to the shielded position. Surveys of the patient and the HDR unit verified that the source was returned to the shielded position. The HDR console indicated that 41.8 seconds had elapsed with source extended. The Patient received an estimated dose of 105 cGy. The patient was informed of the event and no further patients were treated that day. Electa was contacted and a service engineer arrived that same afternoon. He was unable to reproduce the fault condition. Electa is currently investigating the internal performance log of the unit. The physicist performed a complete QC and no aberrations were noted. The HDR unit seems to be performing properly. The last source exchange was on August 14, 2015. Source activity on 9/10/15 was approximately 8 curies. New York event # NY-15-08 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 51099 | 27 May 2015 05:00:00 | Agreement State | Agreement State Report - Lost Iodine-125 Medical Seeds | The following report was received from the State of Texas via email: On May 29, 2015, a licensee notified the Agency (Texas Department of State Health Services) that it was unable to locate a package containing approximately 41.2 millicuries of Iodine-125 seeds. The package had been received at the licensee's facility on May 26, 2015, and per the licensee's procedures, it was delivered to the nuclear medicine department and left in the designated area. However, the staff in the nuclear medicine department had been allowed to leave due to a slow schedule. On May 27, 2015, when staff returned, they were unable to locate the package. The licensee conducted a facility wide search. The (licensee's) materials management employee that placed the package in the nuclear medicine department and the housekeeping employee that cleaned the department the previous night were interviewed. The housekeeper reported, (to have) not removed any boxes from the department. The licensee was unable to identify anyone else had entered the department. The facility's waste container had been picked up and taken to the landfill earlier that morning. The licensee checked with the landfill and learned it does have a radiation monitor but the container from the hospital had not set it off. The contents of the container had already been covered over in the landfill. The patient's procedure was canceled and re-scheduled. The licensee has changed its procedures for radioactive material package delivery by the facility's materials management to the nuclear medicine department to prevent reoccurrence. The licensee is continuing its search for the package. An investigation into this event is ongoing. The Agency (Texas Department of State Health Services) has withheld the name of the licensee (and license number and location) in accordance with Texas state law. Further information will be provided as it is obtained in accordance with SA-300. Texas Incident #: I-9317 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | ||
| ENS 51037 | 30 April 2015 05:00:00 | Agreement State | Agreement State Report - Ruptured Iodine Seed During Removal | The following was received from the State of Texas via email: On May 4, 2015, licensee's Radiation Safety Officer (RSO) reported to the Agency (Texas Department of State Health Services) that he had been notified today that on Thursday, April 30, 2015, a physician had ruptured an I-125 seed during removal from a patient. The seed was used for localization in a breast treatment procedure. The seed activity was 357 microCuries at the time of treatment on 4/30/15. The seed was identified as leaking after removal and in a container in the pathology department. The physician had screened the patient with a probe in the tissue/lesion and no radioactivity was found. No overexposure to the patient or doctor had occurred. The RSO stated he was preparing a full detailed report. Further information will be provided in accordance with SA300 guidelines. Texas Incident # I-9310 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.
This report is retracted based on the following: More complete information was obtained from the licensee. The seed covering was damaged by the physician during excision of tissue from patient. The patient was thoroughly checked following the excision (standard procedure) and there was no radiation detected. There was radioactivity detected in the excised tissue by pathology after seed was removed from the tissue. The licensee identified and remediated all contamination and managed processing of tissue to prevent further contamination. No aspect of the event met any reporting criteria. It has been determined this was not a reportable event. Notified R4DO (Taylor) and NMSS Events Notification via email. | ||
| ENS 50810 | 12 January 2015 05:00:00 | Agreement State | Agreement State Report - Medical Misadministration During Cancer Treatment | The following information was received from the New York State Department of Health Bureau of Environmental Radiation Protection via fax: (The New York State Department of Health) NYSDOH received telephone notification from a licensee reporting a therapy misadministration involving a patient undergoing treatment of vaginal cancer. The treatment involved the use of a GammaMedplus iX brachytherapy HDR remote afterloader utilizing an Iridium-192 radiation source. The patient was administered the treatment using a vaginal applicator for proper placement of the therapy source. However, the vaginal applicator was improperly placed within the organ, which resulted in the irradiation of healthy tissue and significantly less radiation to the cancer site. Three treatments were given to the patient by the same oncologist over a three week period. Each treatment was prescribed to provide approximately 600 to 700 centigray of absorbed radiation. Preliminary investigations show that the therapy equipment was functioning properly and the treatment plan was appropriate. The licensee is investigating the oncologist's procedures. A written report will be sent to (the New York State Department of Health) DOH within seven days with more detailed information. NY Report #: NY-15-02 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 43496 | 11 July 2007 06:00:00 | Agreement State | Agreement State Report - Moisture Gauge Source Disconnected from Cable | The State provided the following information via facsimile: This is the initial notification for an incident that occurred on 7/11/07. A broad-scope licensee reported the loss and recovery of a 50 mCi, Am:Be source from a CPN Model 503DR soil moisture gauge. The gauge was being used as part of an irrigation/moisture study in an agricultural field located about 10 miles south of Sterling, CO. The licensee reported that the source/detector assembly became disconnected from the cable during use, and fell to the bottom of a test hole. The gauge users notified their RSO, and he was able to respond to the scene, retrieve the source, and place it back into the shielded position within the gauge using a remote handling tool. There were no radiation exposures to the gauge users or members of the public, and the RSO estimated his exposure to be less than 20 millirem. The licensee has contacted the manufacturer and is investigating the cause of the problem. | ||
| ENS 43301 | 7 March 2007 04:00:00 | Agreement State | Agreement State Report - Medical Event | The State provided the following information via facsimile: A brachytherapy misadministration involving a 31year old female patient with a history of vaginal cancer was reported to NYS DOH BERP on 3/9/07. The patient was successfully treated to 5590 cGy to the target volume using external beam (IMRT) therapy and she was to receive 2500-3000 cGy via interstitial brachytherapy with both Cesium-137 and lridium-192 (seeds in ribbons) sources. The medical physicist developed a treatment plan as directed by the authorized user/ radiation oncologist using a commercial treatment planning software application. Eleven ribbons with 8 seeds each and an activity of 1.855 mgRaEq per Ir-192 (3.19 mCi) seed were ordered from Best Industries. Hospital owned Cs-137 sources were selected for use. The medical physicist verified source strength of all sources. The oncologist reviewed and approved the plan. He prescribed a total dose of 2500 cGy to be delivered to the 50 cGy-isodose line for a total treatment time of 50 hours. At 2:30 PM on 3/6/07 the sources were placed into the patient. A Syed template was used to place the ribbons and the Cs-137 sources were loaded into a tandem applicator. On 3/7/07, late in the morning, the medical physicist performed a manual check of the treatment plan calculations and identified a significant discrepancy - the hand calculations indicated a significantly higher dose rate than what was generated from the treatment planning software. An investigation ensued, which included consultation with the TPS vendor's application specialist. After several hours of investigation it was determined that the original treatment plan was in error, and at 5:30 PM on 3/7/07, after 27 of the intended 50 hour treatment time, the radiation oncologist decided to remove the sources (from the patient). Instead of the intended 2500cGy, the patient received an estimated dose of 4590 cGy and the anterior rectal dose was approximately 7300 cGy. The licensee provided a written report as required, and DOH staff performed an on-site investigation on 3/21/2007. Cause and contributing factors: 1. The primary error was the use of an inappropriate Dose Rate Factor in the TPS. The value used corresponded to the DRF for Air Kerma however the source strength entered was in MgRaEq. The physicist should have changed the units of source strength or entered the correct DRF. 2. Changing the units of activity in the TPS does not generate a prompt for a new Dose Rate Constant. 3. During the physics review it was determined that acceptance testing of this treatment planning software did not include Iridium-192. The acceptance testing covered Cesium -137 and Iodine -125 seeds which where the only materials being used at the time. If this testing had been performed the physicist would have been more likely to recognize that the treatment planning system does not automatically select the correct dose rate factor when the source strength units are changed. 4. There was no check of the preplan before the seeds arrived although there was sufficient time (sources ordered 2/27/07). The plan was approved on 3/6/07. 5. Neither the physicist nor the radiation oncologist had prepared a treatment with Ir-192 in six years and the physicist had not used this particular TPS for Ir-192 implants. It would have been prudent to have an additional review or outside review in order to verify there were no oversights or errors. 6. The double check was not done until after the day after sources had been implanted. Again while the physicist was observing the minimum requirements of Part 16 it would have been prudent to perform a check of the calculations either prior to the implant or immediately thereafter. Corrective action: The policy and procedures have been changed to require a check of calculations for any single fraction brachytherapy treatment to be performed and approved prior to initiation of treatment. Patient condition and follow-up: The radiation oncologist disclosed that the patient is at risk for radiation cystitis, rectal proctitis and more importantly, fistula formation between the rectum and the vagina. The patient will be monitored closely over the next year by both her gynecologic oncologist and the radiation oncologist. The patient is currently being treated with broad spectrum antibiotics along with daily treatments in a hyperbaric oxygen chamber. NY Event No: NYS-DOH 07-001
This event has been reviewed and determined to be a reportable 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 46895 | 1 January 2005 04:00:00 | Agreement State | Agreement State Report - Dose Administered >20% Different from Prescribed Dose | The following information was provided by the State of New York via email: A patient was prescribed 11 mCi of Iodine-131 for hyperthyroidism but received 7 mCi. Discovered during routine NYS DOH (New York State Department of Health) inspection on 10/18/2007. DOH staff reviewed a memo from the physicist to the RSO discussing the event, but their concern was only that the expiration date on the capsule was 12/28/04 (consultation with the pharmacy after the fact indicated that it was still acceptable to us this dose). A 'left-over' capsule from the previous week (15 mCi on 12/27/2004) with activity of 7 mCi on 01/01/2005 was administered to a patient who was prescribed 11 mCi with the permission of the RSO. Additional dose was ordered and an additional 4 mCi was administered the following day so they RSO did not think it was a misadministration. Follow-up letter from RSO concluded that there was no adverse effect on the patient. Corrective actions included changing procedures and staff training on proper course of action to take in the future and incident reporting requirements. Incident is closed. New York Report Id No.: NY-11-09 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. |