ENS Event | |
|---|---|
04:00 Sep 6, 2022 | |
| Title | |
| Event Description | The following was submitted by the MA Department of Public Health (Agency) by email:
On 9/8/2022, 0930 EDT, [the] licensee reported potential medical event under license 60-0432 for Sirtex Wilmington LLC SIR-Spheres Y-90 microspheres (SS&D MA-1229-D-101-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 18 to 22.8 percent or more. A portion of the Y-90 0.5 GBq microsphere therapy treatment delivered to patient liver on 9/6/22 remained in the delivery system causing delivery of 0.386 GBq to 0.41 GBq Y-90 of the prescribed 0.5 GBq. The error was reported to the RSO the next morning. The licensee stated the cause, including possible clogged catheter, has not yet been determined. The prescribing physician has been notified. Notification of the referring physician and patient is pending. The licensee stated no negative health effects to patient due to situation. No additional Y-90 therapy treatment is expected due to this situation. Licensee to submit written report within 15 days of discovery date. This is a next day reportable medical event per regulation. The investigation is ongoing. The Agency considers this event docket to still be open. 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. |
| Where | |
|---|---|
| Beth Israel Deaconess Medical Ctr Boston, Massachusetts (NRC Region 1) | |
| License number: | 60-0432 |
| Organization: | Ma Dept Of Public Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+60.7 h2.529 days <br />0.361 weeks <br />0.0831 months <br />) | |
| Opened: | Bruce Packard 16:42 Sep 8, 2022 |
| NRC Officer: | Bethany Cecere |
| Last Updated: | Sep 8, 2022 |
| 56097 - NRC Website | |
Beth Israel Deaconess Medical Ctr with Agreement State | |
WEEKMONTHYEARENS 560972022-09-06T04:00:0006 September 2022 04:00:00
[Table view]Agreement State Underdose of Y-90 Microspheres 2022-09-06T04:00:00 | |