Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56946 | 1 February 2024 05:00:00 | Agreement State | Lost Source | The following is a summary of information received from the Georgia Radioactive Material Program (the Department) via email: The licensee's Assistant Director of Radiation Safety contacted the Department on February 1, 2024, at 1700 EST, to report a missing source. He stated he was notified that morning that a germanium-68 Phantom, for use with a PET/MRI (positron emission tomography/magnetic resonance imaging) machine was reported missing. It has a reference activity of 55 MBq / 1.5mCi. During a follow up call from the Department, the Assistant Director stated the source was delivered and accounted for Monday, January 29, 2024, then reported missing February 1, 2024. The source was in a restricted area and locked in the hot lab. The Assistant Director stated they have created a police report and are awaiting surveillance footage. The licensee believes it may have been thrown away accidentally, therefore they are also searching their dumpsters. Georgia Incident Number: 77
The following is a summary of information received from the Georgia Radioactive Material Program (the Department) via email: The Assistant Director of Radiation Safety contacted the Department on 02/02/24 to provide an update on the steps being taken to find the lost source. They had informed the police department and opened an investigation. Security was also assisting in the investigation. The radiopharmacy that supports Emory University, called on 02/05/24 and reported their driver accidentally removed the source. The source was returned on 02/05/24 and the Assistant Director of Radiation Safety completed the check in and the leak test on the source. Notified R1DO (Lilliendahl), NMSS Events Notification, and ILTAB via email. 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 56007 | 20 July 2022 04:00:00 | Agreement State | Dose Misadministration | The following information was provided by the licensee via email: This is a preliminary report. A male patient was prescribed 100 millicuries of lutetium-177. He was delivered with 204 millicuries instead on July 20. This was the patient's third round of lutetium-177. The first two rounds were delivered at 100 millicuries as prescribed. Patient has been notified of the misadministration per a phone call from the prescribing physician. Emory University will send a more thorough report of the misadministration. More information is to follow. Georgia Incident No: 55 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 55850 | 11 April 2022 04:00:00 | Agreement State | Lost/Missing Source | The following is a synopsis of an email received from the state of Georgia: On April 14, 2022, the state of Georgia received the following complaint from the licensee's Assistant Radiation Safety Officer (ARSO): the licensee had a shipment of Y-90 seeds that was supposed to be delivered from Sirtex on the morning of April 11, 2022 for a procedure. The package did not arrive. The ARSO was notified on April 12, 2022 and reported the information to the state of Georgia on April 13, 2022. The package contained 81 milliCi of Y-90 spheres. The ARSO was unable to obtain any information about the location of the shipment from the common carrier. Georgia Incident Number: 53
The following is update was received from the state of Georgia via email: On April 25, 2022, Georgia received notice that the package had been located and is being returned to Sirtex. Georgia has closed the incident. Notified R1DO (Young) and ILTAB and NMSS Events Notification via email. 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 54974 | 29 October 2020 04:00:00 | Agreement State | Dose Delivered Differs by Greater than 20 Percent | The following was received from Georgia Radioactive Materials Program (GA RMP) via email: On Oct 30, 2020, (GA RMP) received an email, from the Assistant RSO (Radiation Safety Officer, Emory University), informing (GA RMP) that a second Y-90 TheraSpheres event occurred on Oct 29, 2020. A patient was administered with 16.2 mCi of Y-90 TheraSpheres using a high flow microcatheter and a larger syringe. The product representative from Boston Scientific was there to consult with the authorized users and technologist prior to treatment. Once it appeared that the micro catheter and Y-90 line and vial were in proper positioning, the Y-90 was administered. Subsequently, the line was flushed three times using approximately 50-60 ml of saline. After the procedure, all items were surveyed and calculated that only 7.3 mCi of Y-90 was administered. Since all waste was surveyed as a whole and not independently from each item, the Assistant RSO did not have the information to discern whether residual Y-90 remained in each product (micro-catheter, line, and vial). Until they can determine the causes of the misadministration, Emory has halted TheraSpheres administration at Emory at Midtown, and substituted Y-90 Sirspheres where they can. Emory University Hospital also uses TheraSpheres, but has not reported any problems. Emory investigation is ongoing. (GA RMP) will provide follow-up information as it is obtained. Georgia Incident No: 32 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 54967 | 23 October 2020 04:00:00 | Agreement State | Dose Delivered Differs by Greater than 20 Percent | The following was received from the Georgia Radioactive Materials Program (the Program) via email: The Y-90 event (occurred) on October 23, 2020. The AU ((Authorized User)) notified the Assistant RSO ((Radiation Safety Officer)) on October 26 and then subsequently notified our Program on October 27, 2020. The reason for the delay notifying the Program was both the Radiation Safety Officer (RSO) and Assistant Radiation Safety Officer (ARSO) were furloughed on Friday ((October 23)) and they did not check their emails until Monday. They used Monday to gather information before contacting the State Program. The patient was administered with 1.58 GBq using a 10 mL syringe. The reason for the 10 mL syringe was a small gauge catheter was used. The line was subsequently flushed 3 times with saline solution to ensure the Y-90 was pushed through. After the procedure, the catheter was removed and surveyed along with the vial to determine residual activity. It was calculated that there was more residual (activity) than expected. Though it is has not been clearly determined the cause of the excess residual (activity), it is thought to be either not enough saline was used to push the Y-90 through or it got stuck in the catheter. The ARSO and the Authorized User will discuss the cause of the event, best way to prevent occurrence, and (perform) patient follow-up. The licensee will follow-up with a report within 15 days. In the interim, the licensee is required to submit a copy of the written directive, Y-90 procedure and checklist, and the rational why they used a small catheter gauge. The actual dose delivered was 1.039 GBq (65.5 percent). Georgia Incident No: 31 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 53468 | 21 June 2018 04:00:00 | Agreement State | En Revision Imported Date 7/3/2018 | EN Revision Text: AGREEMENT STATE REPORT - DOSE MISADMINISTRATION The following information was received from the State of Georgia via email; RMP (Georgia Radioactive Materials Program) received a call regarding an event that occurred at the main Emory Campus. A 57 year old male was treated on June 21, 2018 with 81.1 mCi of Y-90 Therasphere. The treatment site was the right lobe of the liver. Approximately an hour after the treatment the patient was scanned. The scan indicated that approximately 80% of the administered dose went to the left lobe, 10% went to the right lobe and some went to the stomach and some went to the 1st portion of the duodenum. It was determined there was a vessel spasm during the treatment that caused the theraspheres to shunt to the left lobe of the liver. 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. Georgia Incident Report # 3.
The following information was received from the State of Georgia via email: (The Georgia Radioactive Materials Program) received Emory's report regarding the Y-90 procedure and verified the backflow to the left lobe was due to shunting. Based on this information, (Georgia has) determined that this is not a medical event. All documentation will be filed in the licensee's file and electronically. Notified the R1DO (Powell) and the NMSS Events Group via email. | ||
| ENS 52979 | 24 August 2017 04:00:00 | Agreement State | Agreement State Report - Dose Delivered 20% Greater than Prescribed and Greater than 50 Rem to the Targeted Area | The following information was received from the State of Georgia via email: Emory University had new software installed for their HDR on 2/2/2016. During the time span of 3/2016 through 6/2017 (five) 5 patients received doses that were greater than 20% (percent) and greater than 50 rem to the targeted area. The misadministration was due to a software defect with Elekta's Oncentra Brachy Software version 4.5.2. using the ring applicator. The licensee was only aware of the defect on Aug 22, 2017 when Elekta notified all of their customers of the defect. Emory unofficially notified the State of Georgia on Aug 24, 2017 of a possibility that several of their patients may have been involved in a medical event. The medical event was confirmed on Sept 19, 2017 that (five) 5 patients were involved in a medical event. Cause and Corrective Actions: The events were due to a software issue utilizing the Oncentra Brachy Software version 4.5.2. A misadministration occurred due to an inconsistent step size when treating the ring source path. A source step size of 2.5 mm was planned. What was reported in the case explorer was a 5 mm step size. "Device/Associated Equipment: Oncentra Brachy Software version 4.5.2. in a Elekta Nucleotron MicroSelection v3 HDR using a ring applicator. The targeted area that received the greater than 50 rem was the tissue of the upper vaginal wall. The defect in the equipment is identified and described in EN #52922. 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 49917 | 27 February 2014 04:00:00 | Agreement State | Agreement State Report - Yttrium 90 Medical Event | The following information was received from the State of Georgia via email: Event Narrative: A patient was treated with Y-90 microspheres for cholangiocarcinoma. This was a bilateral disease that would require the treatment of both lobes of the liver. Significant tumor burden was in the central (segment IV) and medial sections. The medical team decided to treat the left lobe first as a result. For the first treatment, 54.05 mCi was to be delivered to the left lobe. It had an expected dose of 69.0 Gy to the liver. Due to issues with hepatic arterial anatomy not previously anticipated, the medical team could not properly position the catheter. Because it was a bilateral disease that would eventually require the treatment of both lobes, they decided to move forward with the procedure. Of the calibrated activity of 52.6 mCi, a post-therapy survey of the vial showed 88% of the dose or 46.3 mCi was delivered. A post-delivery Bremsstrahlung scan showed excellent coverage of Segment IV, with some minor coverage in the right lobe due to the arterial anatomy. 21.8 mCi was localized to Segment IV, and the approximate remainder, 24.5 mCi, ended up in the right lobe. There was no significant extrahepatic activity seen. The medical team considered the treatment to be successful due to the patient's bilateral disease. The authorized user intended to treat the right lobe next, and the team reports that the treatment plan will be adjusted to take into account the diseased areas which were treated. There should be no adverse reaction from this initial treatment. Cause and Corrective Actions: Occurred due to an arterial aberration causing a the interventional radiologist to be unable to canulate the artery. The hepatic arterial anatomy was different the day of treatment than the initial shunt study suggested on 5 February 2014. The patient's medical team decided to proceed with the catheter orifice just at the origin of the segment IV hepatic artery. The shunt fractions then resulted differently from the intended treatment for that day. The medical team and RSO are continuing to discuss if any preventative actions can be achieved. Treatment with Y-90 microspheres is reported to be complicated by the degree that the disease and prior treatments have affected liver vasculature. This makes it hard to plan for these scenarios pre-treatment. Generic Implications: Post treatment scans for Y-90 were reported by the licensee not to be a common practice, but they seem vital for determining if a treatment meets reportable limits. Procedure Administered: Bilateral radioembolization of liver with Y-90 microspheres. Intended Dose: 54.05 mCi (69.0 Gy) to left lobe of liver. Actual Dose: 21.8 mCi to Segment IV of left lobe and 24.5 mCi to the right lobe. Patient and Referring Physician Notified: Informed following the procedure's post-delivery Bremsstrahlung scan. 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 48441 | 24 May 2011 04:00:00 | Agreement State | Agreement State Report - Y-90 Therasphere Spill | The following information was obtained from the State of Georgia via facsimile: Description of Event: A spill involving Y-90 microspheres (SIR-Spheres) that occurred on May 24, 2011 at Emory University Hospital (and) was reported by the Deputy Radiation Safety Officer. During an embolization treatment using Y-90 microspheres, resistance was encountered when flushing the catheter following the initial successful microsphere administration. The authorized user examined the catheter which was found to be occluded. Preparations were made to continue the administration with a second measured dose, but this was halted when further examination showed evidence of a leak between the Y-90 vial and the catheter. The procedure was postponed until contamination controls were complete. The patient received the completion of the prescribed dose pursuant to the Authorized User's written directives when the Interventional Suite was available for use on the following day. Describe clean-up actions taken by RCP (Georgia Radiation Control Program): No action performed by RCP but the licensee sealed the Y-90 shielding and cart and removed (them) for decay and evaluation. The floor and equipment were decontaminated by licensee radiation safety staff. List radiation measurements taken by RCP: No measurements performed by the RCP but the licensee initiated spill containment procedures (and surveyed) the staff before allowing anyone to exit the room. Some minor contamination was discovered on staff clothing and shoes, but no contamination was detected on the skin of staff after removal of affected items. The deputy RSO surveyed the patient and had a bremsstrahlung scan of patient. No contamination was found on the patient during the scan. List any other actions required of RCP: The licensee is storing all waste from this event for decay and subsequent investigation. Georgia Incident Summary number GA-2011-61i. | ||
| ENS 45246 | 5 August 2009 04:00:00 | Agreement State | Agreement State Report - Medical Dose Different than Prescribed | During an embolization procedure delivering Yttrium-90 spheres to the liver an interruption occurred resulting in only 35 Gy of the 52 Gy prescribed dose being delivered. The interruption was due to unexpected contamination due to a leaking septum v-vial Contamination was contained in a container and did not enter the patient. The patient and referring physician will be notified. GA report number: 2009-09i. 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 44331 | 31 May 2008 04:00:00 | Agreement State | Agreement State - Possible Overexposure | Emory University Health Physics Department received notification of a film badge reading with a Beta Dose Reading of 49919mR. This report is only preliminary at this point. Period of exposure: 5/1/2008 to 5/31/2008 Deep Dose: 240 mR Lens Dose: 240 mR Beta Dose: 49919 mR The assigned shallow dose was changed to 50,160 mrem due to the beta reading of 49,919 mrem. The other doses, including the ring badge reading, are not out of line with what she and her coworkers in PET-CT receive regularly. (The employee) typically only works with (F-18)FDG (fleurodeoxyglucose). These readings are consistent with a contaminated badge. I will confer with Landauer as to whether contamination with FDG might result in a reading like this, as I suspect. The employee is currently vacationing out of the country and will return July 10, 2008. The investigation will be completed at that time. |