Event Notification Report for October 02, 2024
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
10/01/2024 - 10/02/2024
EVENT NUMBERS
57359
57359
Non-Agreement State
Event Number: 57359
Rep Org: IU Health Arnett
Licensee: Indiana University Health Arnett
Region: 3
City: Lafayette State: IN
County:
License #: 13-32535-02
Agreement: N
Docket:
NRC Notified By: Amanda White
HQ OPS Officer: Eric Simpson
Licensee: Indiana University Health Arnett
Region: 3
City: Lafayette State: IN
County:
License #: 13-32535-02
Agreement: N
Docket:
NRC Notified By: Amanda White
HQ OPS Officer: Eric Simpson
Notification Date: 10/02/2024
Notification Time: 14:17 [ET]
Event Date: 10/02/2024
Event Time: 12:30 [EDT]
Last Update Date: 10/04/2024
Notification Time: 14:17 [ET]
Event Date: 10/02/2024
Event Time: 12:30 [EDT]
Last Update Date: 10/04/2024
Emergency Class: Non Emergency
10 CFR Section:
35.3045(a)(1) - Dose <> Prescribed Dosage
10 CFR Section:
35.3045(a)(1) - Dose <> Prescribed Dosage
Person (Organization):
Havertape, Joshua (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Havertape, Joshua (R3DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
MEDICAL EVENT - Y-90 UNDERDOSE
The following information was provided by the licensee via phone:
A SIR-Spheres treatment to the liver of a patient was planned for 17.3 millicuries (mCi) of yttrium-90 (Y-90). During the dose application to the patient, leakage was noted by a nuclear medical technician. The attending physician tightened the connection between the syringe and catheter such that leakage was no longer observed. After the procedure was completed, a nuclear medicine worksheet was completed. The numbers on the worksheet showed that only 8.67 out of 17.3 mCi had been applied to the liver. This represents an underdose of approximately 50 percent. No other organs were impacted because of the underdose event.
* * * UPDATE ON 10/04/2024 AT 1014 EDT FROM AMANDA WHITE TO NATALIE STARFISH * * *
The following information was provided by the licensee via email:
"When the physician started the injection of Y-90 SIR-Spheres from the delivery system, it was noted that there was leakage coming from the connection tubing that attached to the patient's catheter from the radial access point. The injection process was quickly stopped, and the physician tightened the connection to prevent any further leakage. No further leakage was noted after the connection was tightened.
"After a Y-90 SIR-Spheres administration, the calculated patient dose delivered to the patient was determined to be less than 50 percent of the written directive prescribed dose. The prescribed dose was 17.3 mCi and the calculated patient dose delivered was 8.67 mCi. The intended dose to liver was 30 Gy and the intended dose to the tumor was 120 Gy. The estimated dose to the liver is 15 Gy.
"There were no effects to the patient with the exception that the patient was under-dosed.
"After discussion with the treating physician, they will now be using a new microcatheter and will do a test flush prior to delivering the dose to ensure no leakage.
"The patient and their significant other were notified by the referring physician. The referring physician also discussed with the patient that they might treat them again depending on how well they tolerated their last treatment."
Notified the R3DO (Havertape) and NMSS Events Notifications via 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 licensee via phone:
A SIR-Spheres treatment to the liver of a patient was planned for 17.3 millicuries (mCi) of yttrium-90 (Y-90). During the dose application to the patient, leakage was noted by a nuclear medical technician. The attending physician tightened the connection between the syringe and catheter such that leakage was no longer observed. After the procedure was completed, a nuclear medicine worksheet was completed. The numbers on the worksheet showed that only 8.67 out of 17.3 mCi had been applied to the liver. This represents an underdose of approximately 50 percent. No other organs were impacted because of the underdose event.
* * * UPDATE ON 10/04/2024 AT 1014 EDT FROM AMANDA WHITE TO NATALIE STARFISH * * *
The following information was provided by the licensee via email:
"When the physician started the injection of Y-90 SIR-Spheres from the delivery system, it was noted that there was leakage coming from the connection tubing that attached to the patient's catheter from the radial access point. The injection process was quickly stopped, and the physician tightened the connection to prevent any further leakage. No further leakage was noted after the connection was tightened.
"After a Y-90 SIR-Spheres administration, the calculated patient dose delivered to the patient was determined to be less than 50 percent of the written directive prescribed dose. The prescribed dose was 17.3 mCi and the calculated patient dose delivered was 8.67 mCi. The intended dose to liver was 30 Gy and the intended dose to the tumor was 120 Gy. The estimated dose to the liver is 15 Gy.
"There were no effects to the patient with the exception that the patient was under-dosed.
"After discussion with the treating physician, they will now be using a new microcatheter and will do a test flush prior to delivering the dose to ensure no leakage.
"The patient and their significant other were notified by the referring physician. The referring physician also discussed with the patient that they might treat them again depending on how well they tolerated their last treatment."
Notified the R3DO (Havertape) and NMSS Events Notifications via 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.