The following was received from the State of
Arizona via email:
On May 22, 2014, the Agency was notified of a medical event that occurred on April 4, 2014 involving Y-90 labeled SIR Spheres.
On April 4, 2014, an adult liver tumor patient was treated with an injection of SIR Spheres. The patient was prescribed 59.4 Gy to the liver, but instead, the actual dose to the liver was approximately 39 Gy. It was determined that the error occurred in the step of transferring the dose from the delivery vial to the dosing vial. The step of drawing up the sterile fluid was inadvertently omitted by the nuclear medicine technologist working alone which led to much less than the expected activity/sphere being transferred to the dosing vial. Only after the completion of the procedure was the large amount of residual activity detected and noted. The physicians noted that physiologic factors can affect the amount of spheres reaching the tumor so the discrepancy of the dose delivered apparently was not alarming or significant to them. The RSO discovered the medical event during a records review and recognized that the patient only received 63% of the prescribed dose.
Arizona First Notice Number: 14-013