Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56272 | 14 December 2022 06:00:00 | Agreement State | Patient Underdose | The following information was provided by the Illinois Emergency Management Agency (The Agency) via email: The Agency was contacted on 12/14/22 by the medical physicist for Alexian Brothers Medical Center to advise that a Y-90 microsphere administration conducted that morning resulted in a reportable under dose. The administered amount was 20.4 percent lower than that specified in the written directive. This was not a stasis case. The licensee has tried multiple times, but has so far been unable to reach the patient for notification. The referring physician has been notified. Agency inspectors have gathered preliminary information but will conduct a reactionary site visit on Tuesday, 12/20/2022. More information will be provided once it becomes available. Illinois Event Number: IL220043
When initially reported, this was not identified as a stasis case. Both the patient and the referring physician were notified within 24 hours. Agency inspectors conducted a reactionary site visit on 12/20/2022. Upon further discussion and investigation, the authorized user (AU) and authorized medical physicist (AMP) believe the procedure may have reached stasis. The AMP acknowledged that additional training needed to be provided to the treatment team regarding procedures reaching stasis. The licensee determined the root cause to be failure to identify stasis. Agency inspectors determined the potential root cause as a failure to follow procedures and lack of sufficient training to the newly hired AU regarding stasis. This incident and the licensee's procedures will be reviewed during the next routine inspection. This matter may be considered closed. Notified R3DO (Edwards) and NMSS Event Notifications via email. 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 54140 | 1 July 2019 05:00:00 | Agreement State | Agreement State Report - Medical Event | The following was received from the state of Illinois via email: The Agency (Illinois Bureau of Radiation Safety) was notified at approximately 1530 CDT on 7/1/19, that a medical event had occurred at Alexian Brothers Medical Center, in Elk Grove Village. The circumstances are near identical to those in an event reported by the licensee in February of this year (EN53859). An attempted intravascular brachytherapy procedure utilizing a Novoste BetaCath 3.5F System was aborted when the source train could not successfully reach the intended treatment site after three attempts. The source train was retracted without complication and there were no indications of kinks in the delivery catheter. Aborting the procedure resulted in an underdose exceeding 20 percent of the prescribed dose (prescribed dose was 18.4 Gy of Y-90 and delivered dose was 0.0 Gy). The three attempts also resulted in an exposure exceeding 50 rem to tissue other than the treatment site (treatment site was in the circumflex artery). The source train stopped each of three times 10mm proximal to the treatment site in the junction between the left coronary artery and the circumflex artery. The inadvertently exposed region received approximately 0.98 Gy or a dose equivalent of approximately 100 rem. A reactionary inspection was conducted by Agency staff on the morning of July 2, 2019. A written report was received by the licensee that same day in which tortuous patient anatomy was identified as the root cause. Agency inspectors will meet with the authorized user on the afternoon of July 3, 2019, to discuss each step of the intravascular brachytherapy procedure in an effort to further isolate the root cause. No adverse medical impact is expected to the patient as a result of this event, per the authorized user. Patient has been notified and referring physician was present. This report will be updated as additional information becomes available." Illinois Item Number: IL190016 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 53859 | 4 February 2019 06:00:00 | Agreement State | Agreement State Report - Underdose Exceeding 20 Percent of the Prescribed Dose | The following was received via email from the state of Illinois: Alexian Brothers Medical Center has advised that an attempted intravascular brachytherapy procedure utilizing a Novoste BetaCath System (containing a sealed source of Sr-90) appears to have resulted in a medical event with an underdose exceeding 20 percent of the prescribed dose. The source train was unable to reach the target location after three attempts, stopping approximately 60mm proximal. The source train was retracted without complication after a 'few seconds' during each attempt. The prescribed exposure was 18.4 Gy. The licensee estimates the unintended area receiving dose (aorta) received 0.006 Sv, less than the 0.5 Sv reporting requirement. This matter is being reported due to the fact the intended tissue received less than 20 percent of the intended dose. This event is ongoing and the report will be amended as details become available. This will be reported to NMED today. There is no adverse medical consequence expected for the patient. Item Number: IL 190006 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 53531 | 14 May 2015 05:00:00 | Agreement State | Agreement State Report - Brachytherapy Source Did Not Fully Retract | The following report was received by e-mail from the state of Illinois: During a routine inspection (Illinois Emergency Management) Agency inspectors discovered an unreported event that occurred on May 14, 2015. On that date an intravascular brachytherapy procedure was attempted using two BRX-0346 extra-long delivery catheters with a Novoste transfer device and a 40mm Best Vascular, Inc. Sr-90 source train. On the initial treatment attempt, the source would not extend to the treatment location and was promptly returned to the transfer device. A kinked catheter was suspected and a second BRX-0346 XL catheter was put in place. The same train was sent into the second catheter and the same inability to reach the treatment location encountered. At this point, the hydraulic return mechanism failed to return the source train to the transfer device. The licensee's emergency procedure was employed and the entire system was manually removed from the patient. The transfer device, delivery catheter and source train were placed in a temporary storage container and locked in the hot lab. The patient was surveyed and no radioactivity was found to be above background. The treatment was aborted. The licensee was able to determine that a deformation in the delivery catheter impeded movement of the source train to the treatment location. The source was found to be lodged in the catheter, approximately 11.3 cm from the attachment point to the transfer device. As a result, exposure occurred in the aortic root. Estimates on the exposure to the surrounding tissue is pending from the licensee. Best Vascular representatives were reportedly notified and arrived at the licensee's site the following day for evaluation and return shipping to the manufacturer. A deformation in the catheter was confirmed as the root cause. The event was not reported to the State. Supporting documentation was reviewed on 7/30/18 and determined to be, at a minimum an equipment-related event. Pending exposure estimates, this is also being entered as a possible medical event and will remain open while the investigation continues. Radionuclide: Sr-90 Activity: 58.65 mCi (2.17005 GBq) Dose: 18.4 rad (184 mGy) Illinois Item Number: IL180031 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. |