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Event Notification Report for September 02, 2020

U.S. Nuclear Regulatory Commission
Operations Center

EVENT REPORTS FOR
09/01/2020 - 09/02/2020

EVENT NUMBERS
5487554882

Fuel Cycle Facility
Event Number: 54875
Facility: Global Nuclear Fuel - Americas
Region: 2     State: NC
Unit: [] [] []
RX Type: Uranium Fuel Fabrication
Comments: Leu Conversion (Uf6 To Uo2)
Leu Fabrication
Lwr Commerical Fuel
NRC Notified By: Phillip Ollis
HQ OPS Officer: Donald Norwood
Notification Date: 09/02/2020
Notification Time: 16:52 [ET]
Event Date: 09/02/2020
Event Time: 10:27 [EDT]
Last Update Date: 09/02/2020
Emergency Class: Non Emergency
10 CFR Section:
PART 70 APP A (c) - Offsite Notification/News Rel
Person (Organization):
MARK MILLER (R2DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Event Text
CONCURRENT REPORT FOR OFFSITE NOTIFICATION

"At approximately 1027 EDT on September 2, 2020, the New Hanover County Deputy Fire Marshall was notified per State code requirements that the fire suppression system encompassing a part of the Fuel Manufacturing Operation (FMO) was impaired due to planned sprinkler head modifications. Additional compensatory measures were enacted. The system was restored at approximately 1300 EDT today (9/2/2020) and the Deputy Fire Marshall informed of restoration. Because the New Hanover County Deputy Fire Marshall was notified, a concurrent notification to the NRC Operations Center is being made per 10 CFR 70, Appendix A(c)."

The licensee will notify Region 2.


Agreement State
Event Number: 54882
Rep Org: GEORGIA RADIOACTIVE MATERIAL PGM
Licensee: Cancer Treatment Centers of America
Region: 1
City: Newman   State: GA
County:
License #: GA 1632-1
Agreement: Y
Docket:
NRC Notified By: Irene Bennett
HQ OPS Officer: Jeffrey Whited
Notification Date: 09/04/2020
Notification Time: 15:01 [ET]
Event Date: 09/02/2020
Event Time: 00:00 [EDT]
Last Update Date: 09/04/2020
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
Person (Organization):
JOSEPHINE AMBROSINI (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Event Text
AGREEMENT STATE REPORT - MEDICAL EVENT - UNDERDOSE

The following was received from the Georgia Radioactive Materials Program via email:

"At the end of the administration of Y-90 SIR Spheres [for the treatment of tumors in the right lobe of the liver], the delivery vial (D-Vial) appeared to overfill as the radiologist was attempting to mix the spheres with a 50/50 solution of contrast and 5 percent dextrose/glucose (D5W). The radiologist noticed some clumping and after attempting to gently disperse the Spheres, he gave a couple hard pushes of the contrast/D5W into the D-Vial. At that time, he noticed the leak. He examined the septum and found it to be dry. As a precaution the radiologist put Durabond on top of the septum. Further examination showed that the material leaked out of the sides of the crimped vial top rather than the septum. The procedure was stopped to prevent further contamination.

"The event occurred while using SIRTEX new SIROS delivery system. The SIRTEX representative was present providing guidance to the radiologist as this was the first time he used the new system.

"It is estimated that 75 percent of Y-90 SIR-Spheres were administered to the patient [Prescribed Activity: 3.1 GBq (83.7 mCi); Delivered Activity (estimated): 2.87 Gbq (77.7 mCi)]. It is likely that the residual activity was over estimated due to contamination of the SIROS delivery dome. The usual waste from the procedure is contained in a 1-liter Nalgene containers and then placed in a Lucite shield for dose rate measurements to determine the residual activity. The Siros delivery dome could not be measured in the same geometry and likely resulted in an increased dose rate and underestimate of the total dose delivered.

"At this time, the prescribing physician indicated he does not expect any adverse effects for the patient and is awaiting the dosimetry evaluation from the patients PET/CT Scan.

"Attempts have been made to recreate the event without success. There is speculation regarding the size of the dose and that the number of Spheres may have been a factor (larger than typically administered). Representatives from SIRTEX indicate that this has not been an issue at other sites.

"Prior and subsequent studies with the new SIROS delivery system were successful with less activity.

"Further evaluation of the equipment to determine why the vial leaked, will be performed following decay and return the manufacturer."

Georgia Incident Number: 30

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.