The following report was received from the State of
California via email:
At approximately 1000 PDT on May 5, 2015, a medical event occurred during a Y-90 Therasphere procedure. The prescribed dose to the organ (liver) was 12,000 rem, but the delivered dose was 6,920 rem. This event meets the 10 CFR 35.3045(1)(i) 24-hour report criteria since the dose differed from the prescribed dose by more than 50 rem to an organ (5080 rem under dose) and the total dose delivered differed from the prescribed dose by 20 percent or more (42% under dose). Although the equipment indicated the entire dose had been delivered to the patient, a large amount of the dose was is still in the tubing and vial and had not actually been delivered to the patient as indicated. The licensee will contact the manufacturer to assist in finding the root cause of the malfunction to determine whether it was an equipment malfunction, operator error, or both. The treating physician is also the prescribing physician. The licensee has contacted the physician to verify if the physician has notified the patient and if there was any effect on the individual from this event. The licensee will provide the written report within 15 days as required which will also describe what actions will be taken to prevent reoccurrence.
California Report Number: 050616.
- * * RETRACTION AT 1229 EDT ON 8/21/2015 FROM ROBERT GREGER TO MARK ABRAMOVITZ * * *
The following was received via e-mail:
The California Radiation Control Program would like to retract the subject event notification for the medical event at UCLA. Subsequent evaluation determined that the patient received the prescribed dosage. Some contamination on the exterior of the equipment utilized in the therapeutic dosage administration was determined to have misled the licensee staff to initially believe that an under-dosage to the patient had occurred.
Notified the R4DO (Hay) and NMSS Events Resource (via e-mail).
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.