Event Notification Report for April 02, 2019
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
04/01/2019 - 04/02/2019
EVENT NUMBERS
53971
Agreement State
Event Number: 53971
Rep Org: MA RADIATION CONTROL PROGRAM
Licensee: UMASS MEMORIAL HEALTH CARE
Region: 1
City: WORCHESTER State: MA
County:
License #: 60-0096
Agreement: Y
Docket:
NRC Notified By: TONY CARPENITO
HQ OPS Officer: RYAN ALEXANDER
Licensee: UMASS MEMORIAL HEALTH CARE
Region: 1
City: WORCHESTER State: MA
County:
License #: 60-0096
Agreement: Y
Docket:
NRC Notified By: TONY CARPENITO
HQ OPS Officer: RYAN ALEXANDER
Notification Date: 04/03/2019
Notification Time: 12:25 [ET]
Event Date: 04/02/2019
Event Time: 10:42 [EDT]
Last Update Date: 04/03/2019
Notification Time: 12:25 [ET]
Event Date: 04/02/2019
Event Time: 10:42 [EDT]
Last Update Date: 04/03/2019
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
10 CFR Section:
AGREEMENT STATE
Person (Organization):
MATT YOUNG (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
MATT YOUNG (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - MEDICAL EVENT - UNDERDOSE ADMINISTRATION OF Y-90 MICROSPHERES
The following was received from the Commonwealth of Massachusetts via e-mail:
"On 4/2/19, 1430 EDT, the licensee reported a medical event involving Nordion TheraSpheres (SS&D NR-0220-D-131-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a two-vial Y-90 62 mCi (13 mCi and 49 mCi vials) microsphere therapy treatment delivered to the patient's liver on 4/2/19 was stuck in the catheter causing delivery of approximately 37 mCi Y-90. This was discovered immediately after treatment. The administered dose to the treatment area differed from the prescribed dose by approximately 40 percent. The licensee stated that the primary cause was an equipment malfunction. The first vial of 13 mCi was delivered fully, but only 24 mCi of the second vial containing 49 mCi was actually administered to the patient. The prescribing physician, referring physician and patient have been notified. The licensee stated that there were no negative health effects to the patient due to the situation. No additional Y-90 therapy treatment will be required. Corrective actions will include removal of the suspect equipment (catheter) and return of said equipment to the manufacturer for evaluation. A larger diameter catheter will be used during future therapy treatments. The licensee will submit a written report within 15 days of the discovery date. Agency on-site investigation is pending. This is a next day reportable medical event per regulations.
"Investigation ongoing. Agency considers this event docket to still be OPEN."
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 was received from the Commonwealth of Massachusetts via e-mail:
"On 4/2/19, 1430 EDT, the licensee reported a medical event involving Nordion TheraSpheres (SS&D NR-0220-D-131-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a two-vial Y-90 62 mCi (13 mCi and 49 mCi vials) microsphere therapy treatment delivered to the patient's liver on 4/2/19 was stuck in the catheter causing delivery of approximately 37 mCi Y-90. This was discovered immediately after treatment. The administered dose to the treatment area differed from the prescribed dose by approximately 40 percent. The licensee stated that the primary cause was an equipment malfunction. The first vial of 13 mCi was delivered fully, but only 24 mCi of the second vial containing 49 mCi was actually administered to the patient. The prescribing physician, referring physician and patient have been notified. The licensee stated that there were no negative health effects to the patient due to the situation. No additional Y-90 therapy treatment will be required. Corrective actions will include removal of the suspect equipment (catheter) and return of said equipment to the manufacturer for evaluation. A larger diameter catheter will be used during future therapy treatments. The licensee will submit a written report within 15 days of the discovery date. Agency on-site investigation is pending. This is a next day reportable medical event per regulations.
"Investigation ongoing. Agency considers this event docket to still be OPEN."
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.