Event Notification Report for January 19, 2024
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
01/18/2024 - 01/19/2024
EVENT NUMBERS
56930
56930
Agreement State
Event Number: 56930
Rep Org: WA Office of Radiation Protection
Licensee: Swedish Medical Center
Region: 4
City: Seattle State: WA
County:
License #: WN-M008
Agreement: Y
Docket:
NRC Notified By: Boris Tsenov
HQ OPS Officer: Brian P. Smith
Licensee: Swedish Medical Center
Region: 4
City: Seattle State: WA
County:
License #: WN-M008
Agreement: Y
Docket:
NRC Notified By: Boris Tsenov
HQ OPS Officer: Brian P. Smith
Notification Date: 01/22/2024
Notification Time: 18:11 [ET]
Event Date: 01/19/2024
Event Time: 12:00 [PST]
Last Update Date: 01/31/2024
Notification Time: 18:11 [ET]
Event Date: 01/19/2024
Event Time: 12:00 [PST]
Last Update Date: 01/31/2024
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
O'Keefe, Neil (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
O'Keefe, Neil (R4DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
EN Revision Imported Date: 2/1/2024
EN Revision Text: AGREEMENT STATE REPORT - Y-90 MICROSPHERE MISADMINISTRATION
The following is a summary of information received via email from the Washington Office of Radiation Protection:
On the afternoon of Friday, January 19th, a Pluvicto (radiopharmaceutical) dose was not administered properly. A typical administered dose may have up to 2 to 4 mCi of residual activity after a 200 mCi administration. However, for this administration there was 43 mCi of residual activity and only 149 mCi of calculated administered activity for a 200 mCi prescribed dose. Pluvicto is a six fraction, six administration regimen with about six weeks between each administration, and this was the patient's fourth fractional dose. Treated as a single administration treatment, this constitutes a medical event as the dose administered activity of 149 mCi is more than 20% less than the 200 mCi prescribed dose. The final report will be sent in 15 days.
Washington Event Number: WA-24-003
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.
* * * UPDATE ON 1/29/2024 AT 1401 EST FROM BORIS TSENOV TO NATALIE STARFISH * * *
The following information is a synopsis of information provided by the Washington State Radioactive Materials Section:
A lutetium 177 (drug name: Pluvicto) dose was prescribed to be 200 mCi. The calculated dose administered to the patient was about 149 mCi, based upon the measured residual. The underdosing occurred due to a method of folding and crimping the intravenous tube with a hemostat and gauze instead of utilizing the kit provided clamp. The hospital supply chain of the intravenous kit was recently changed and the needed clamp was thought to be missing. To prevent future crimping of the intravenous tube, the use of hemostat and gauze will no longer be used.
This dose was the fourth dose of six prescribed to the patient, with six weeks between each administration. There is no expected change in the patient's treatment or prognosis based on the underdosing of the fourth fraction of six and no additional actions are required.
Final report will be sent in 15 days.
Washington Event Number: WA-24-003
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.
Notified R4DO (Agrawal) and NMSS (email).
EN Revision Text: AGREEMENT STATE REPORT - Y-90 MICROSPHERE MISADMINISTRATION
The following is a summary of information received via email from the Washington Office of Radiation Protection:
On the afternoon of Friday, January 19th, a Pluvicto (radiopharmaceutical) dose was not administered properly. A typical administered dose may have up to 2 to 4 mCi of residual activity after a 200 mCi administration. However, for this administration there was 43 mCi of residual activity and only 149 mCi of calculated administered activity for a 200 mCi prescribed dose. Pluvicto is a six fraction, six administration regimen with about six weeks between each administration, and this was the patient's fourth fractional dose. Treated as a single administration treatment, this constitutes a medical event as the dose administered activity of 149 mCi is more than 20% less than the 200 mCi prescribed dose. The final report will be sent in 15 days.
Washington Event Number: WA-24-003
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.
* * * UPDATE ON 1/29/2024 AT 1401 EST FROM BORIS TSENOV TO NATALIE STARFISH * * *
The following information is a synopsis of information provided by the Washington State Radioactive Materials Section:
A lutetium 177 (drug name: Pluvicto) dose was prescribed to be 200 mCi. The calculated dose administered to the patient was about 149 mCi, based upon the measured residual. The underdosing occurred due to a method of folding and crimping the intravenous tube with a hemostat and gauze instead of utilizing the kit provided clamp. The hospital supply chain of the intravenous kit was recently changed and the needed clamp was thought to be missing. To prevent future crimping of the intravenous tube, the use of hemostat and gauze will no longer be used.
This dose was the fourth dose of six prescribed to the patient, with six weeks between each administration. There is no expected change in the patient's treatment or prognosis based on the underdosing of the fourth fraction of six and no additional actions are required.
Final report will be sent in 15 days.
Washington Event Number: WA-24-003
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.
Notified R4DO (Agrawal) and NMSS (email).