The following information was received from the
Massachusetts Radiation Control Program (the Agency) via email:
On 8/3/2022 at 1444 EDT, the licensee reported [to the agency (MA Department of Public Health Radiation Control Program)] a medical event 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 two-site Y-90 16.2 mCi microsphere therapy treatment delivered to the patient liver on 8/2/22 remained in the delivery system causing delivery of 12.7 mCi Y-90 of the prescribed 16.2 mCi. The error was discovered the next morning during final post-treatment calculations. The administered dose to the treatment area differed from the prescribed dose by 21.6 percent. The licensee stated that the cause, including possible equipment malfunction, has not yet been determined. The prescribing physician and referring physician have been notified. The physician is to notify the patient (not yet confirmed). The licensee stated no negative health effects to the patient due to the situation. No additional Y-90 therapy treatment is expected due to this situation. The licensee stated that all Y-90 was accounted for. The licensee is to submit a written report within 15 days of discovery date. This is a next day reportable medical event per regulation.
Investigation is ongoing. The agency considers this event docket to still be open.
MA Event Number: TBD
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.