ENS 56689
ENS Event | |
|---|---|
04:00 Aug 21, 2023 | |
| Title | Medical Equipment Failed to Function as Designed |
| Event Description | The following information was received via email from the Pennsylvania Department of Environmental Protection (the Department):
On August 21, 2023 the licensee informed the Department of a medical event where the equipment failed to function as designed. This is reportable under 10 CFR 30.50(b)(2). A patient was scheduled for an intravascular brachytherapy (IVBT) patient treatment using a Beta-Cath Strontium 90 device (s/n 91273) and upon source retraction the source failed to return to the transfer device due to a kink in the catheter. An emergency 'bailout' procedure was performed, with the cardiologist removing the delivery catheter and guidewire from the patient. The delivery catheter was left attached to the transfer device and placed it into the temporary plexiglas 'bailout' box. The patient was surveyed to confirm the source had been removed. The 'bailout' box was visually inspected and surveyed to confirm the source was in the catheter in the box. This box was then transferred to the radiation oncology secure storage area. The device will be returned to the manufacturer for inspection. No overexposures were reported. The cause of the event is unknown at this time. The Department will perform a reactive inspection. More information will be provided as received. PA Event Report ID Number: PA230022 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 received via email from the Department. The event type has been changed from a medical event to a Part 30 equipment event. The Department has learned that the authorized user said that treatment was complete and the source did not enter the device within 3 seconds so they started emergency removal of catheter from the patient and placed it in the 'bailout' box; total time from end of treatment to the catheter/device in the emergency box was approximately 10 seconds. The kink in the catheter was noted after it and the source were approximately 15 cm from where it entered the patient thus no overexposure or unintended dose. Device make, model, serial number: Best Vascular, Inc, A1000 Series Models, Transfer Device s/n 91273. Radionuclide: Sr-90; Jacketed Radiation Source Train s/n ZB948 (60 mm source train) (24 sources). Source strength(s): 3.13 Gbq (84.6 mCi) total; [3.52 mCi/source * 24 sources]; Assay date 12/3/2003; Activity as of August 21, 2023 = 1.92 Gbq (51.9 mCi) total. Dose patient received:18.4 Gray @ 2 mm; (vessel 3.0 mm). Dose patient prescribed:18.4 Gray @ 2mm (vessel 3.0 mm). Notified R1DO (Gray) and NMSS Events Notification email group. |
| Where | |
|---|---|
| Allegheny Health Network, Pittsburgh, Pa Pittsburgh, Pennsylvania (NRC Region 1) | |
| License number: | PA-1659 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+33.62 h1.401 days <br />0.2 weeks <br />0.0461 months <br />) | |
| Opened: | John Chippo 13:37 Aug 22, 2023 |
| NRC Officer: | Donald Norwood |
| Last Updated: | Aug 23, 2023 |
| 56689 - NRC Website | |
Allegheny Health Network, Pittsburgh, Pa with Agreement State | |
WEEKMONTHYEARENS 566892023-08-21T04:00:00021 August 2023 04:00:00
[Table view]Agreement State Medical Equipment Failed to Function as Designed 2023-08-21T04:00:00 | |