ENS 57377

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v t e 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

ENS 57377 +/-
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:	Oct 11, 2024
57377 - NRC Website
v • d • e

v t e Emergency Notification System
Northwestern Memorial Healthcare with Agreement State
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