The following was received from the
Virginia Radioactive Materials Program via email:
On December 3, 2020, at 1540 EST, the Virginia Radioactive Materials Program (VRMP) received a report from the licensee via telephone that a medical event occurred on December 3, 2020, as a result of a therapy procedure using SIR-Spheres Yttrium-90 resin microspheres. The prescribed dosage to the tumor was 27.9 milliCuries. The actual delivered dosage to the tumor was 20.03 milliCuries, which resulted a difference of 28.3 percent (under-dosage). The preliminary report indicated that this difference was determined based on the measurement of the remaining residual activity in the delivery system.
Referring physician was notified and an Authorized User was requested to contact the patient concerning the event. The VRMP is working with the licensee to obtain additional information and this report will be updated once the licensee's investigation is complete and the information is received.
Event Report ID No.: VA20006
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.
- * * RETRACTION ON 12/08/20 AT 0922 EST FROM ASFAW FENTA TO SOLOMON SAHLE * * *
The following retraction was received from the Commonwealth of Virginia via email:
On 12/7/2020, VRMP received a report from the licensee re-investigation the event by two independent teams on 12/4/2020 for verification. Both teams found an error on the first measurement of the remaining residual radioactivity in the delivery system. Based on the teams' new measurements, the dosage left over after the procedure was now calculated to be 1.4 milliCuries of Yttrium-90 versus the original value of 8 milliCuries. Those measurements were corrected for the radioactive decay to the time of the procedure. The new value is within the allowed dose deviation of a normal procedure (new estimate 5 percent deviation of prescription). Thus, VRMP requests the NRC Operation Center retract this event report.
Notified R1DO (Bower) and
NMSS Event Notification via email.