ENS 55557

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v t e 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.

ENS 55557 +/-
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
v • d • e

v t e Emergency Notification System
Tufts Medical Center with Agreement State
WEEKMONTHYEAR2023-03-29T02:30:00 [Table view]
[ENS list for Tufts Medical Center]

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