Event Notification Report for August 05, 2023
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
08/04/2023 - 08/05/2023
EVENT NUMBERS
56661
56661
Agreement State
Event Number: 56661
Rep Org: PA Bureau of Radiation Protection
Licensee: University of Pennsylvania
Region: 1
City: Philadephia State: PA
County:
License #: PA-0131
Agreement: Y
Docket:
NRC Notified By: John S. Chippo
HQ OPS Officer: Karen Cotton-Gross
Licensee: University of Pennsylvania
Region: 1
City: Philadephia State: PA
County:
License #: PA-0131
Agreement: Y
Docket:
NRC Notified By: John S. Chippo
HQ OPS Officer: Karen Cotton-Gross
Notification Date: 08/05/2023
Notification Time: 11:07 [ET]
Event Date: 08/05/2023
Event Time: 11:07 [EDT]
Last Update Date: 08/07/2023
Notification Time: 11:07 [ET]
Event Date: 08/05/2023
Event Time: 11:07 [EDT]
Last Update Date: 08/07/2023
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Bickett, Brice (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Bickett, Brice (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - MEDICAL UNDERDOSE
The following information was provided by the PA Bureau of Radiation Protection (the Department) via email:
"On August 4, 2023, the licensee, University of Pennsylvania, informed the Department of an under-dose incident involving yttrium-90 (Y-90) TheraSpheres. The event is reportable per 10 CFR 35.3045(a)(1).
"On August 3, 2023, it was determined that 71.0 percent of the prescribed dose to the target tissue was delivered for the above treatment. The only information relayed to the Department so far was that there were no spills or leaks in the system. The DEP [Department of Environmental Protection] is currently in contact with the licensee and will update this event as soon as more information is provided.
"The cause of the event is unknown at this time. The Department will perform a reactive inspection. More information will be provided as received."
Event Report ID No: PA230021
* * * UPDATE ON 08/07/2023 AT 1207 EDT FROM JOHN CHIPPO TO ERNEST WEST * * *
"An administration of Y-90 TheraSpheres occurred with no apparent difficulties. No leaks or spills were identified, as corroborated by post administration monitoring which identified no contamination. However, when the waste was measured it was determined that less than 80 percent (72.6 percent) of the prescribed activity was administered. It is estimated that 21.18 mCi of the 29.18 mCi prescribed dose was administered. The patient and prescribing physician have been informed. No adverse effects to the patient are present nor are any anticipated."
Notified R1DO (Dimitriadis) and NMSS (Email).
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.
The following information was provided by the PA Bureau of Radiation Protection (the Department) via email:
"On August 4, 2023, the licensee, University of Pennsylvania, informed the Department of an under-dose incident involving yttrium-90 (Y-90) TheraSpheres. The event is reportable per 10 CFR 35.3045(a)(1).
"On August 3, 2023, it was determined that 71.0 percent of the prescribed dose to the target tissue was delivered for the above treatment. The only information relayed to the Department so far was that there were no spills or leaks in the system. The DEP [Department of Environmental Protection] is currently in contact with the licensee and will update this event as soon as more information is provided.
"The cause of the event is unknown at this time. The Department will perform a reactive inspection. More information will be provided as received."
Event Report ID No: PA230021
* * * UPDATE ON 08/07/2023 AT 1207 EDT FROM JOHN CHIPPO TO ERNEST WEST * * *
"An administration of Y-90 TheraSpheres occurred with no apparent difficulties. No leaks or spills were identified, as corroborated by post administration monitoring which identified no contamination. However, when the waste was measured it was determined that less than 80 percent (72.6 percent) of the prescribed activity was administered. It is estimated that 21.18 mCi of the 29.18 mCi prescribed dose was administered. The patient and prescribing physician have been informed. No adverse effects to the patient are present nor are any anticipated."
Notified R1DO (Dimitriadis) and NMSS (Email).
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.