ENS Event | |
|---|---|
17:25 Nov 2, 2021 | |
| Title | Y-90 Microsphere Medical Event |
| Event Description | The following information was received from the Commonwealth of Massachusetts via email:
On November 2, 2021, 3:00 PM [EDT], licensee reported medical event under license 60-0160 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 20 percent or more. A portion of a Y-90 5 mCi microsphere therapy treatment delivered to patient liver on November 2, 2021 remained in the delivery system causing delivery of approximately 3.67 mCi Y-90 of the prescribed 5 mCi. The error was discovered immediately after treatment. Administered dose to treatment area differed from prescribed dose by approximately 27 percent. Licensee stated the cause, including possible equipment malfunction, has not yet been determined. Prescribing physician, referring physician and patient have been notified. Licensee stated no negative health effects to patient due to situation. No additional Y-90 therapy treatment would be required due to this situation. Licensee stated all Y-90 was accounted for. Licensee stated 5 mCi prescription was unusually small compared to previous procedures (range 9-to-39 mCi with 15 mCi being the most prescribed dose). Licensee to submit written report within 15 days of discovery date. This is a next day reportable medical event per regulation. Investigation ongoing. Agency considers this event docket to still be OPEN. Report by Anthony Carpenito, 11/3/2021. |
| Where | |
|---|---|
| Tufts Medical Center Boston, Massachusetts (NRC Region 1) | |
| License number: | 60-0160 |
| Organization: | Ma Radiation Control Program |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+18.72 h0.78 days <br />0.111 weeks <br />0.0256 months <br />) | |
| Opened: | Anthony Carpenito 12:08 Nov 3, 2021 |
| NRC Officer: | Jim Drake |
| Last Updated: | Nov 3, 2021 |
| 55557 - NRC Website | |
Tufts Medical Center with Agreement State | |
WEEKMONTHYEARENS 564402023-03-29T02:30:00029 March 2023 02:30:00
[Table view]Agreement State Dose Above Prescribed Dose ENS 555572021-11-02T17:25:0002 November 2021 17:25:00 Agreement State Y-90 Microsphere Medical Event ENS 490492013-05-17T04:00:00017 May 2013 04:00:00 Agreement State Massachusetts Agreement State Report - Medical Event Concerning Gamma Knife Therapy ENS 508322012-02-10T05:00:00010 February 2012 05:00:00 Agreement State Agreement State Report - Medical Overdose 2023-03-29T02:30:00 | |