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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 57097 | 30 April 2024 05:00:00 | Agreement State | Medical Event | The following was provided by the Illinois Emergency Management Agency (the Agency) via email: On April 30, 2024, the Agency was notified by Northwestern Memorial HealthCares radiation safety officer of an yttrium-90 (Y-90) TheraSphere underdose. There were no adverse patient impacts reported, and the treatment is scheduled to be repeated the following week. The initial information indicated an underdose of Y-90 TheraSpheres of near 100 percent. Additional information is forthcoming, and Agency staff will be on-site to perform a reactive inspection on May 5, 2024. Updates will be made when available.
The following information was provided by the Illinois Emergency Management Agency (the Agency) via email: Based on the May 2, 2024, reactive investigation, agency inspectors determined that this case qualifies as a medical event under 335.1080(a)(1). The authorized user (AU) stated that no negative health effects were expected for the patient and that the patient will be retreated in the future. The patient and referring physician were notified of the event within 24 hours as required. Agency inspectors determined the potential root cause as the clumping of microspheres due to the overtightening of the tuohy luer lock. This matter may be considered closed pending further information. Notified R3DO (Szwarc) and NMSS Events Notifications (Email). IL Event Number: IL240009 A Medical Event may indicate potential problems in a medical facilitys use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 55842 | 11 April 2022 05:00:00 | Agreement State | Patient Received Dose Less than Prescribed | The following information was provided by the Illinois Emergency Management Agency (the Agency) via email: The Radiation Safety Officer for Northwestern Memorial HealthCare, contacted the Agency on 4/12/2022 to advise of a Y-90 microsphere administration in which the patient received only 70 percent of the prescribed dose. Of note, the (authorized user) noticed sluggish flow during the first flush of saline through the device, possibly due to a kink in the micro catheter as it exits the base catheter. No contamination or other issues were identified. No adverse patient impacts are expected. The (authorized user) was satisfied that the dose was adequate as delivered and will assess with MRI in 1 month as per protocol. The Agency will dispatch inspectors to review procedures and determine a root cause. Item Number: IL220012 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 55716 | 27 January 2022 06:00:00 | Agreement State | Patient Underdose | The following information was received from Illinois Emergency Management Agency (Agency) via phone and E-mail: At 1545 CST on 1/27/2022, the Agency was contacted by Northwestern Memorial Hospital (IL-01037-02) of a potential medical event. No adverse patient impact reported. The administration was able to be completed that same day. This event was reported to the NRC Headquarters Operations Officer (1/28/22) this afternoon. Agency inspectors performed a reactive inspection on 1/28/2022 at Central DuPage Hospital. On 1/27/2022, a written directive to deliver 3.25 GBq Y-90 SIR-Spheres to the right hepatic artery was prepared. The procedure performed that same day was halted prematurely due to an occlusion of microspheres in the delivery line. (Surveys of the delivery equipment indicated no microspheres were delivered to the patient.) To compensate for the underdose, the licensee created two additional written directives and administered two doses of 1.55 GBq Y-90 SIR-Spheres each without incident. The licensee is continuing their investigation into root cause. (Agency will review the investigation results.) Item Number: IL220002 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 55704 | 15 February 2021 06:00:00 | Agreement State | Patient Underdose | The following information was received from Illinois Emergency Management Agency (Agency) via E-mail: Agency inspectors performed a routine inspection on 1/6/2022. During a review of Y-90 TheraSphere procedures, inspectors noted an unreported medical event which occurred on 2/15/2021. On 2/15/2021, a written directive to deliver 1.93 GBq Y-90 TheraSpheres to the right hepatic artery was prepared. The procedure performed that same day was halted prematurely due to an unwinding of the male luer lock connector and only 0.49 GBq were administered. To compensate for the underdose, the licensee created an additional written directive and administered 1.17 GBq Y-90 TheraSpheres without incident (on the same day as the initial procedure). The licensee was under the impression that this was not a reportable medical event since they were able to compensate the dose with an additional vial they had on hand and were ultimately able to deliver the intended dose. Item Number: IL220001 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 46792 | 27 April 2011 05:00:00 | Agreement State | Agreement State Report - Underdose Due to Clumping in the Delivery Device | The following information was obtained from the State of Illinois via email: The Radiation Safety Officer at Northwestern Memorial Hospital contacted the Illinois Emergency Management Agency on April 26th and reported that a medical event involving radiolabled Theraspheres had occurred. The treating physician attempted to perform radioembolization by placing the Y-90 microspheres in the treatment site using the appropriate Nordion Microsphere Delivery Device. However, increased resistance was felt in the administration syringe and a clump of microspheres developed between the needle injector assembly and the microcatheter connection during the initial bolus flush. Administration was halted as soon as the microsphere flow was slowed and a clump was visualized. Following a second attempt to complete the flush, the microspheres began layering within the outlet tubing. Further flushing of the system with saline did not alter the position of the remaining microspheres. The procedure was halted. Analysis of the system showed that a significant amount of the original dose had not been delivered as intended to the right hepatic lobe of the liver. Approximately 80 percent of the dose was not administered as a result of the failure. The primary cause of this incident is due to the clumping of the microspheres. However, the reason for the clumping is unknown. The intended dose of Y-90 was 59.4 mCi (2198.8 Mbq) for an exposure of 9750 rad (97.5 Gy). The administered dose was 22.7 mCi (839.9 Mbq) for an exposure of 3760 rad (37.6 Gy). Illinois Report Number: IL11049 | ||
| ENS 44816 | 29 January 2009 06:00:00 | Agreement State | Agreement State Report - Personnel Contamination from I-131 Spill in Hot Lab | The radiation safety officer (RSO) for Northwestern Memorial Hospital called the Agency (State) to advise that a technician had spilled a significant quantity of I-131 in their hot lab. The technician was preparing a radioiodine therapy dose of 100 milliCi for ingestion by a patient when the spill of the liquid occurred. The technician had been removing the vial from the fume hood to perform a dose calibration when the material slipped from his hands and broke on the floor of the hot lab. The technician was contaminated on his hands, torso and legs. The material, although small in volume, was concentrated, such that even small drops of the liquid exhibit high dose rates. Initial decontamination efforts managed to reduce the contamination on the individual such that the contamination only remained on their hands. The initial measured dose rate was approximately 7 milliR/h. The spill victim was excluded from the cleanup process to reduce the possibility of a significant uptake to their thyroid. All individuals involved in the clean up as well as the technician took prophylactic KI. According to the RSO, decontamination will continue until only fixed contamination remains. He estimated that as much as 80% of the contamination had been contained/removed by the time of his call a few hours after the event. Dose rates in the area were initially over 50 milliR/h. Additional shielding was moved into the area so that medically necessary nuclear medicine procedures could be completed while the decontamination was finished. Dose rates behind the shielding indicated less than 1 milliR/h. Bioassays will be conducted during subsequent days to determine the extent of any uptake that has occurred for those involved. Arrangements were made for the radiopharmacy to be shut down and operations relocated to another temporary facility within the hospital. Waste generated from the initial decontamination effort was secured within the pharmacy hot lab in the fume hood. Access will be restricted to only those granted leave by the RSO to reenter the lab. Arrangements have been made for an Agency (State) inspector to go to the site to ascertain and verify the dose rates in the area, the extent of contamination and ensure that bioassays are being conducted properly. Depending on the results of those assessments, the Agency (State) may take additional action. Incident number: IL0900010 | ||
| ENS 42354 | 21 February 2006 06:00:00 | Agreement State | Agreement State - Loss of Iridium Seed Strand Following Medical Treatment | The following is a summary of information provided by the State via email: The licensee's Radiation Safety Officer indicated that a gynecological implant of seeds contained in a nylon ribbon were missing at the completion of a patient treatment. The "strand" contained 10 seeds of 0.675 milliCi, each, which was part of a treatment that included 9 total strands of both Cs-137 and Ir-192 sources. The lost strand contained 10 Ir-192 seeds. A resident physician removed the strands at the end of the treatment on the evening of 2/18/06. The treatment had begun on 2/15/06. After returning the strands to the radiation oncology lab it was noted that only 8 strands were present, rather than the 9 which were initially implanted. The patient was thoroughly surveyed and eventually x-ray'd to confirm the missing strand did not remain in the patient. The operating room, the patient's room, the remaining linen and trash from the patient's room, the hallway between the patient's room and the radiation oncology source storage location, the entire nursing floor, the radiation oncology department, the hospital's linen holding facility, the biohazardous waste holding facility and loading docks were all monitored without any success of locating the strand. The patient had been essentially immobilized for the treatment and had received a Foley catheter for relieving her bladder. As such, use of the toilet facilities were not likely (although they too were monitored). Surveys were conducted with instruments that were likely to detect the radiation field associated with almost 7 mCi of Ir-192 (i.e., 4 to 5 milliRem/hr at 1 meter) by the staff. Interviews were conducted with the nursing staff to determine additional details regarding handling of trash and linen from the patient's room. Although the licensee's surveys showed no elevated levels present at the time, the licensee indicated that waste and linen from the room would be held pending potential surveys by the Division. The licensee has also monitored their contracted biohazardous waste treatment facility in Cicero, IL on 2/20/06 with negative results. They also planned to visit the linen laundering facility in Palwaukee, IL on the slim chance that the strand was carried off in soiled linens that might have been changed during the patient's stay. The resident involved, the residency staff and the residency director received additional instruction regarding established procedures, in conjunction with this event, with regards to explanation of sources and accounting procedures. Similarly, the nursing staff was interviewed and refreshed on established procedures with regards to linen and waste processing from patients' rooms. The patient was scheduled to return for a follow up visit on 2/22/06 at which time she was going to be interviewed again to determine if there was any additional information she could provide to help locate the missing strand. Illinois Report #IL060013
The missing radioactive sources reported by the Illinois Emergency Management Agency (IEMA) on February 21, 2006 at 17:21 from Northwestern Memorial Hospital have been recovered by the facility's radiation safety officer. A radiation monitor alarm was reported to IEMA by the Prairie Hills Landfill staff in Morrison, IL on 2/21/2006. IEMA personnel investigated that alarm yesterday (02/22/06) and confirmed the presence of Ir-192 by gamma spectroscopy as part of a load of trash that was traced back to the hospital's laundry service provider. Arrangements were made to have the ribbon of 10 sources picked up by hospital staff this morning and returned to the hospital for proper disposal. Notified R3DO (Hills) and NMSS EO (Morell) 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. 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 |