ENS Event | |
|---|---|
05:00 Feb 11, 2025 | |
| Title | Medical Event |
| Event Description | The following information was provided by the Massachusetts Radiation Control Program (MRCP) via email:
On 02/13/25, at 1138 EST, the licensee, Beth Israel Deaconess Medical Center (Massachusetts license number: 60-0432) reported a medical event involving yttrium-90 Theraspheres (Manufacturer: Nordion BWXT ITG Canada, Inc.; Model: TheraSphere Y-90 glass microsphere system; sealed source and device registration number: NR-0220-D-131-S). The total administered activity differed from prescribed treatment activity as documented in the written directive by 20 percent or more. The medical event occurred on 2/11/25. The activity delivered was calculated to be 45.5 percent of the prescribed activity (prescribed activity: 4.13 GBq, delivered activity: 1.88 GBq). The event was identified on 2/12/25. The licensee reported that there was no adverse effect on the patient. The authorized user, referring physician, and patient have been notified. MRCP will follow up with the licensee's radiation safety officer (RSO) to determine event cause and corrective actions. The device has been taken out of service while the investigation remains open. The MRCP considers this event open. The MRCP will follow up with a special inspection of the licensee. 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 Center Boston, Massachusetts (NRC Region 1) | |
| License number: | 60-0432 |
| Organization: | Ma Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+78.62 h3.276 days <br />0.468 weeks <br />0.108 months <br />) | |
| Opened: | Bob Locke 11:37 Feb 14, 2025 |
| NRC Officer: | Ernest West |
| Last Updated: | Feb 14, 2025 |
| 57546 - NRC Website | |
Beth Israel Deaconess Medical Center with Agreement State | |
WEEKMONTHYEARENS 575562025-02-14T05:00:00014 February 2025 05:00:00
[Table view]Agreement State Medical Event ENS 575462025-02-11T05:00:00011 February 2025 05:00:00 Agreement State Medical Event 2025-02-14T05:00:00 | |