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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56254 | 1 December 2022 05:00:00 | Agreement State | Patient Underdose | The following information was provided by the North Carolina Division of Radiation Protection via email: The state of North Carolina Radioactive Materials Branch received a report at 1050 EST on December 2, 2022, from Duke University Medical Center (license number: 032-0247-4) of a possible medical event involving a patient receiving Yttrium-90 therapy for treatment of a liver tumor. The treatment had an intended dosage of 91.6 mCi with a delivered dosage of 54.6 mCi resulting in a 40 percent under dosing that did not appear to involve stasis. The patient and the patient's representative were notified at the time of the treatment and the referring physician was notified the morning of December 2, 2022. The licensee is currently investigating the root cause but initially believes it to be caused by equipment failure. The State is currently investigating and will provide more information as it becomes available. NC Incident No.: NC220015 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 55409 | 26 August 2020 04:00:00 | Agreement State | Lost IODINE-125 Seed | The following information was obtained from the State of North Carolina via email: On 25 August 2020, an iodine-125 (I-125) seed was implanted into a perirectal mass in a patient for the purpose of localization and excisional biopsy. Following implantation, the Imaging team surveyed the needle and patient with a Geiger-Mueller detector per standard procedure to confirm proper placement of the seed within the mass. In addition, a post-implantation CT scan confirmed the presence of the seed within the mass. The seed and patient data were entered into the on-line 'Seed Tracker' software by the Imaging team per standard procedure. Excision of the tumor containing the seed was planned for the next day, and the patient was discharged home. At the time of surgery on 26 August 2020, the operative team was unable to detect the seed within the mass. Although the absence of the seed was documented in the operative note, the surgical team did not report that unusual occurrence to the Imaging team or the Radiation Safety Division. The specimen, which contained no seed and was not labeled as containing a seed, was sent to Surgical Pathology as a routine specimen and was processed as such. However, the Surgical Pathology team failed to notice that an entry for that patient and seed had been made in the 'Seed Tracker'. The error was not detected until an audit of the information in the 'Seed Tracker' was performed by staff of the Imaging teams and the Radiopharmacy in July 2021. The discrepancy between the 'Seed Tracker' data and the labeling and processing of the specimen as 'non-radioactive' was resolved when the surgical team's operative note was consulted. Because locating the seed would have been unlikely and impractical after 10 months (activity estimated to be 4 microcuries), our efforts were focused on investigating the root causes and identifying corrective actions. Probable disposition of lost material: Based upon the confirmation of seed placement in the perirectal mass by survey and CT scan, and its absence upon excision the following day, the seed most likely migrated out the implantation track and was discharged into the sanitary sewer during a bowel movement. Migration of seeds is uncommon but does occur. In this case, it would not have been noticed by the patient. North Carolina Item Number: NC210013 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 54282 | 16 September 2019 04:00:00 | Agreement State | Agreement State Report - Medical Event | The following information is a summary of an email received from the state of North Carolina: On September 16, 2019, a patient at Duke University Medical Center was prescribed 43.2 mCi of Y-90 Theraspheres to the liver, but received 89.6 mCi. While the cause of the misadministration is not clear at this time, it is known that the dose received was intended for a different patient. Both the patient and the authorized user have been informed of the incident. An inspector has been dispatched to conduct a reactive inspection for this event. North Carolina Tracking Number: 190032 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 53591 | 7 September 2018 04:00:00 | Agreement State | Agreement State Report - Administered Dose Lower than Prescribed Dose | The following information was received from the state of North Carolina via email: A patient being treated for liver tumors was prescribed to receive 47.6 mCi of Y-90 microspheres, but instead received only 11.9 mCi (about 25 percent of prescribed). The remainder was in the vial as residual. Because this under-dosing was not due to stasis or emergent patient conditions, and the delivered dose was less than 20 percent of that prescribed, this constitutes a reportable medical event according to the 2016 version (9) of the NRC guidance for Y-90 microspheres. Source: Microspheres Radionuclide: Y-90 Manufacturer: Sirtex Medical Model: Sir-Spheres S/N: Aggregate Investigation is pending for the Medical Event. North Carolina Tracking Number: 180039 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 52580 | 24 February 2017 05:00:00 | Agreement State | Agreement State Report - Medical Event Due to High Dose | The following information was supplied via email from the State of North Carolina: On 2/27/2017 the North Carolina Radiation Protection Section (RPS) received the following notification from Duke University Medical Center, License number 0247-4. A possible Medical Event occurred at Duke University Medical Center on February 24, 2017 involving Y-90 microspheres during a liver embolization procedure. Duke personnel reported to North Carolina Radiation Protection Section (RPS) on February 27, 2017 of the event meeting the reporting requirements for a Medical Event as dictated in NRC Licensing Guidance, Rev. 9 under: Medical Event (ME) Reporting: The licensee shall commit to report any event, except for an event that results from intervention of a patient or human research subject, in which: the total dose or activity administered differs from the prescribed dose or activity, as documented in the written directive, by 20 percent or more, except when stasis or emergent patient conditions are documented and resulted in a total dose or activity administered that was less than that prescribed; At this time, the details provided by Duke University Medical Center for this ME are as follows: Delivered dose was 94 percent higher than the prescribed dose in the Written Directive to the treatment site. The apparent cause appears to be an error in reading the prescribed radioactivity (in GBq) before converting to the administered activity (in mCi), indicating operator error that occurred in the radio pharmacy at Duke University Medical Center. RPS has dispatched an investigator to perform a reactive inspection at Duke University Medical Center. This investigation is ongoing and RPS will have additional information to complete this report. The State on North Carolina does not know if the patient has been notified of the received dose being higher than the prescribed dose. 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 51032 | 30 March 2014 04:00:00 | Agreement State | Agreement State Report - Iodine 125 Seed Left in Patient | The following was received from the State of North Carolina via email: During a recent facility inspection at Duke University Medical Center (License# 0247-4), it was discovered that a lost I-125 seed (National NMED Item #140177) was actually found a couple months later still in the patient's breast tissue. The seed was intended for radioactive seed localization (RSL) of a breast lesion and thought to be excised with the targeted tissue during surgery. Events as follows: -Seed was implanted to patient with 213 uCi on 1/23/2014. -Discovered missing by licensee on 2/27/2014. -Reported lost to NC on 3/21/2014. -Found in patient 3/30/2014, no update given to NC. -Removed from patient breast on 4/1/2014. As of 5/1/2015, the licensee maintains that there was only 12.5 rads received to the 250g of breast tissue and not above the 50 rem for medical event reporting. This is currently under investigation by the NC Radioactive Materials Branch as our preliminary numbers suggest the breast tissue dose could be as high as 66 rem in the maximally exposed 100g of tissue. The licensee is not concerned with overall adverse reaction to the patient health due to them receiving a subsequent external beam radiation treatment that deposited between 300-1100 rads to the affected breast. This possible medical event is tied to the former local NMED Incident# NC 140014 where the source was lost, and it is now being tracked by a new local NMED Incident# NC 150010. 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 46389 | 22 October 2010 18:45:00 | Agreement State | Agreement State Report - Medical Event - Dose Administered in Wrong Location | The following report was received from the State of North Carolina via email: The patient has persistent small cell lung cancer after chemotherapy, in an area that has received prior external beam radiation therapy, and was symptomatic. Therefore, a course of endobronchial brachytherapy with a high-dose rate unit (HDR) was recommended to the left upper and left lower lobe bronchus where the tumor was present. The treatment prescription was 10 Gy x 2 fractions to the target volume as defined in the planning CT. The first treatment was delivered between 2 to 3 pm, on Oct 22, 2010. Unfortunately, due to errors in defining the starting dwelling positions of the source during the treatment planning, the actual dose was delivered to the wrong location along the catheters. Details of the process are described below. After two endobronchial catheters were placed under bronchoscopy in the OR (operating room), the patient was transferred to Radiation Oncology Department where a CT was obtained for treatment planning purposes. The two catheters were positioned correctly based on CT. In the first step of the treatment planning, the locations of the two endobronchial catheters were correctly identified in the CT images. The direction of the catheters was mistakenly reversed afterwards during the treatment planning, thereby changing the starting position of the HDR source. Therefore, instead of the patient being treated correctly to the identified tumor region in the left-sided airways, she was treated to a position more proximally along the path of the catheters (the larynx area). Although the plan was checked by a number of qualified physicists per operational protocol, the subtle orientation error was missed, both in the plan check and in the delivery check. The wrong treatment was delivered around 2:45 pm. The error was identified by the planning physicists when they were working on another patient case, about one hour after the patient's treatment. A computerized 3-D plan was generated to calculate the actual location and dose delivered due to this error. The estimated dose to the neck region was about 15-20 Gy. The plan delivered to the patient was also delivered on radiochromic film to confirm the location of the delivered dose. The attending physician, clinical director, and the director of physics were all notified immediately after the error was identified and confirmed. The Radiation Oncology Department chair was notified by the clinical director. The Radiation Safety Officer was notified also by the chief physicist. The attending physician reviewed the case and the dosimetry, and immediately tried to contact the patient. After several attempts the patient was reached around 6:00 PM and asked to come back to the hospital immediately for observation and prophylactic treatments. The patient was admitted to hospital around 9:00 PM on the same day (the time required for her to travel back to Duke from her home). Licensee's evaluation of why the event occurred: a. Staff physicists were more focused on dose optimization and missed the catheter's orientation. B The wrong orientation was again missed during the plan and delivery checks. C. In addition to calculation checks, there was no experimental check, i.e. delivering dose to the film to verify the distance. The effect, if any, on the individual(s) who received the administration: The patient was admitted to Duke Hospital immediately after the error was discovered. She remained hospitalized for 4 days during which time she remained relatively asymptomatic. She did not develop increasing hoarseness, shortness of breath, or odynophagia. She underwent fiber optic laryngoscopy 36 hours after her treatment which showed minor edema of the supraglottic larynx but no airway compromise. She received the correct treatment while an inpatient, and after one additional day of observation was discharged home. What actions, if any, have been taken or are planned to prevent recurrence: a. Conducted a root-cause analysis of the event among the physicists. B. A new and more detailed standard operational procedure (SOP) for this type of treatment was generated by the members of the Brachytherapy team. C. The existent HDR Patient QA form was edited to add extra check levels that will prevent this error from happening again. D. A new verification procedure was added to the existent set of verification procedures. It involves the delivery of the treatment on Gafchromic film or alternative imaging device to verify the exact starting point of the treatment. This film will be compared with the plan and will have to be approved by two physicists and the attending for each case. Certification that the licensee notified the individual (or the individual's responsible relative or guardian) and if not, why not: The patient was contacted, was returned to Duke and was admitted for evaluation and management. Log # NC 10-47 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. |