Semantic search
| Discovered date | Reporting criterion | Title | Description | LER | |
|---|---|---|---|---|---|
| ENS 56686 | 17 August 2023 04:00:00 | 10 CFR 35.3045(a)(1) | Medical Event - Patient Underdose | The following information was provided by West Virginia University Hospital via telephone and email: It was determined on 8/21/2023, that during a Y-90 (yttrium-90) Thera Sphere treatment performed on 8/17/2023, the delivered dose differed from the prescribed dose by more than 20 percent. The prescribed activity was 101.5 mCi and the administered activity was 3.4 mCi. At the start of the infusion the authorized user (AU) was unable to deliver the microspheres due to a blood clot in the microcatheter. The AU then decided to abort the infusion and reschedule instead of chancing potential contamination that could occur by changing out the microcatheter. The AU had completed the pre-treatment safety checklist with no issues. The AU has made the notification to the referring physician. 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.
It was determined that the dose of yttrium-90 Thera Spheres was not delivered according to the written directive due to an emergent patient condition. Therefore, the incident does not qualify as a reportable medical event. The patient's blood formed a clot within the microcatheter which prevented the passage of Y-90 microspheres. At the onset of administration, the Authorized User (AU) encountered significant resistance in the microcatheter, and they could not flush forward. When troubleshooting the delivery set, the AU visually identified the blood clot within the microcatheter. After several unsuccessful attempts to clear the blood clot, and in consultation with representatives from Boston Scientific, the AU decided to terminate the procedure. On September 1st, the Y-90 prescribed activity, as stated on the written directive, was successfully administered to the patient's hepatic artery. There were no adverse effects to the patient because of the underdose incident. The details of this incident were discussed with NRC inspectors who were on site for a reactive inspection. During those discussions it was concluded that since the patient's blood clotted within the microcatheter, the inability to complete the administration was due to an emergent patient condition. The blood clot within the microcatheter was confirmed by an analysis of the delivery set performed by Boston Scientific's Product Analysis Team. Notified: R1DO (Elise), NMSS Events Notification (E-mail) | |
| ENS 52949 | 5 September 2017 20:30:00 | 10 CFR 35.3045(a)(1) | Brachytherapy Treatment Delivered Dose Less than Prescribed Dose | In compliance with 10CFR35.3045(c), WVU (West Virginia University) Hospitals License # 47-23066-02, Docket # 03020233 is making telephone notification declaring a medical event. On September 5, 2017 a patient was being administered the first fraction of a planned five fraction HDR interstitial brachytherapy treatment, treating the cervix. The written directive prescribed 5, 5Gy fractions for a total dose of 25Gy. During the first fraction, 5 separate interlocks were tripped at which time the manufacturer was contacted (at) 1535 (EDT). Based on discussions between the medical physics team and the manufacturer, the manufacturer determined the error was caused by fluid in the catheter which may have contaminated the source and the afterloader unit. The manufacturer advised to suspend treatment, and stop all use of the afterloader until it could be decontaminated and the source could be exchanged. (Scheduled for September 7, 2017). At the time the treatment was stopped, the patient received 0.32Gy of the planned 5Gy fraction, based on a 12.1 seconds treated of a planned 576.8 second treatment fraction. Based on 10CFR35.3045(a)(1), the fraction of the dose differed by more than 50 rem to organ or tissue, and 10CFR35.3045(a)(1)(iii) the fractionated dose delivered differs from the prescribed dose for a single fraction, by 50 percent or more. In compliance with 10CFR35.3045(e), the patient and referring physician have been notified. Upon decontamination and source exchange the patient is scheduled to complete the treatment per the written directive (September 7-9, 2017). In compliance with 10CFR35.3045(d), a written report will be submitted to the Region One Office within 15 days. The Licensee has notified R1(Gallaghar). 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 52551 | 18 January 2017 05:00:00 | 10 CFR 20.2201(a)(1)(ii) | Lost Iodine-125 Implant Seed | In compliance with 10 CFR 20.2201(a), this report serves as notification of the loss of licensed material under West Virginia University Hospital Broad Scope License 47-23066-02. On January 18, 2017, the Radiation Safety Department discovered that one Iodine-125 seed used in a Radioactive Seed Localization (RSL) procedure was missing. The seed in question had been implanted on November 8, 2016 and contained 241 microCuries of I-125. The patient had surgery to excise the specimen with the seed on the same day as implantation. The specimen went to the Breast Care Center for imaging and then to the Pathology gross room where the seeds are removed and placed into plastic vials to await pick up by Radiation Safety staff. Radiation Safety staff documented that the seed in question plus 3 others were picked up from the gross room on November 9, 2016 and taken to the radioactive waste storage area. The seed was discovered missing on January 18, 2017 during preparation of a return shipment of seeds to the manufacturer. WVU Radiation Safety promptly investigated the cause of the incident and performed thorough radiation surveys in the Pathology gross room, radioactive waste storage area, and specimen blocks in Pathology, however all surveys were indistinguishable from background. WVU Hospital feels it is likely that the seed was extracted from the specimen in the gross room but was never placed into the plastic vial and subsequently ended up discarded in the gross room waste. During pick up by Radiation Safety, the seed was falsely identified by a visual verification as being present in the plastic vial. A blue plastic spacer, which comes preloaded in the syringe with the seed, may have been mistakenly identified as the seed due to its similar size and shape. WVU Hospital has instituted corrective actions to include more intense radiation surveys and better documentation of those surveys to prevent a future occurrence. In compliance with 10 CFR 20.2201(b), please expect a written report within the next 30 days for more details regarding this incident. 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 46074 | 20 January 2010 04:00:00 | 10 CFR 35.3045(a)(1) | Medical Treatment Terminated Prior to Administering Full Dose | A patient's liver was being treated using SIR-Spheres through a catheter. During the administration of the Y-90 SIR-Spheres, the physician believed that there was leakage around the stopper and halted the medical procedure with only 21.9 mCi administered instead of the complete dose of 30.7 mCi i.e. 71% of the prescribed dose. The manufacturer was notified of the potential manufacturing defect and the hospital was directed to ship the delivery apparatus (as is) back to the manufacturer after the Y-90 had decayed. The equipment was returned to the manufacturer on April 5, 2010 and a report was received from the manufacturer on June 21, 2010. "The manufacturer noted that there was leaking but could not conclude that it was a manufacturer defect or if the physician applied too much pressure to the V-vial during the procedure." The patient was notified of the dose received. 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 48201 | 8 October 2005 04:00:00 | 10 CFR 20.2201(a)(1)(i) | Missing Sealed Americium-241 Source | Subject: Official Notification This is to inform the NRC Operations Center that West Virginia University (WVU) Hospitals License # 47-23066-02 is not in possession of Item 6.I. Am-241 sealed sources (Amersham Model Dwg. ARC 10048B and 10040B) with an activity of 9.825 millicuries. NRC Region 1 is aware of this situation and has been working with us to resolve it. In August of 2005, a request was made to remove the item from our license. At that time NRC Region 1, via an October 8, 2005 email control # 137502, requested documentation of the shipment/disposal of the source. Based on NRC Region1 recommendations, on November 1, 2005 West Virginia University Hospitals withdrew the request to remove the item from the license. Control # 137502. In a search of the WVU Radiation Safety Department and Vendor records, no evidence of a shipment of the source was found. It was last listed on our physical inventory on May 7, 1991. The former RSO informed us via phone conversation that he believed it was shipped in the early 1990's. All of the search results were documented in writing to NRC Region 1 on May 23, 2012 during our license renewal process. Control # 576453. There is a current license amendment request to remove the source from our license. Control # 577671. West Virginia University Hospitals is officially notifying the NRC Operations Center at this time to document the situation in an effort to bring the situation to a close, and ultimately remove the source from our license. The licensee has been working with Janice Nguyen in Region 1 to resolve this issue. 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 This source is not amongst those sources or devices identified by the IAEA Code of Conduct for the Safety & Security of Radioactive Sources to be of concern from a radiological standpoint. Therefore is it being categorized as a less than Category 3 source |