ENS Event | |
|---|---|
05:00 Sep 23, 2024 | |
| Title | Therasphere Device Failure |
| Event Description | The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:
The Agency was contacted on October 10, 2024, by Northwestern Memorial Healthcare in Chicago, IL, to advise of a suspected TheraSphere device failure. There was no associated medical event, nor any contamination resulting from the equipment failure. Reportedly, on September 23, 2024, during the administration of Y-90 TheraSpheres, the treatment was immediately halted by the authorized user (AU) following infusion of 3 mL of saline through the system due to observation of excessive air bubbles present in the outlet line. Both the [authorized medical physicist] (AMP) and the AU noticed what appeared to be flakes in the bottom of the 'V' vial and possible microspheres in the outlet line. The source vial and attached microcatheter were removed following standard procedures. The licensee followed the standard protocol and determined that the patient received 42.18 Gy of the prescribed 45.48 Gy. No follow up or medical action was required of the patient. No contamination of staff, patient, or the area was identified. Staff were interviewed to determine possible causes of the leak, with no deviations from the protocol noted. No initial defects in the administration kit were noted, however, after concluding their investigation, the licensee made the determination of a reportable equipment failure on October 9, 2024. The investigation remains ongoing, and a report was sent by the licensee to the manufacturer on October 9, 2024. This matter is reportable under 32 Illinois Administrative Code 340.1220(c)(2). NMED number: IL240023
The following update was provided by the Illinois Emergency Management Agency via email: On May 22, 2025, the manufacturer provided their assessment. They suspect the cause of the event was low flow rate (which allows the microspheres to fall from suspension), possibly due to kinks observed in the microcatheter. Absent the availability of additional data, this matter is considered closed. Notified R3DO (Hills) and NMSS Events Notification (email) |
| Where | |
|---|---|
| Northwestern Memorial Healthcare Chicago, Illinois (NRC Region 3) | |
| License number: | IL-01037-02 |
| Organization: | Illinois Emergency Mgmt. Agency |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+442.95 h18.456 days <br />2.637 weeks <br />0.607 months <br />) | |
| Opened: | Gary Forsee 15:57 Oct 11, 2024 |
| NRC Officer: | Robert A. Thompson |
| Last Updated: | Aug 1, 2025 |
| 57377 - NRC Website | |
Northwestern Memorial Healthcare with Agreement State | |
WEEKMONTHYEARENS 581122026-01-09T06:00:0009 January 2026 06:00:00
[Table view]Agreement State Medical Event ENS 577832025-06-25T05:00:00025 June 2025 05:00:00 Agreement State Unplanned Contamination ENS 577152025-05-15T05:00:00015 May 2025 05:00:00 Agreement State Medical Event ENS 573772024-09-23T05:00:00023 September 2024 05:00:00 Agreement State Therasphere Device Failure 2026-01-09T06:00:00 | |