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The following information was provided by … The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:</br>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. </br>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).</br>NMED number: IL240023</br>* * * UPDATE ON AUGUST 1, 2025 AT 1544 EDT FROM GARY FORSEE TO JON LILLIENDAHL * * *</br>The following update was provided by the Illinois Emergency Management Agency via email:</br>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.</br>Notified R3DO (Hills) and NMSS Events Notification (email)ills) and NMSS Events Notification (email)
05:00:00, 23 September 2024 +
57,377 +
15:57:00, 11 October 2024 +
05:00:00, 23 September 2024 +
The following information was provided by … The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:</br>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. </br>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).</br>NMED number: IL240023</br>* * * UPDATE ON AUGUST 1, 2025 AT 1544 EDT FROM GARY FORSEE TO JON LILLIENDAHL * * *</br>The following update was provided by the Illinois Emergency Management Agency via email:</br>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.</br>Notified R3DO (Hills) and NMSS Events Notification (email)ills) and NMSS Events Notification (email)
Has query"Has query" is a predefined property that represents meta information (in form of a <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Subobject">subobject</a>) about individual queries and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
00:00:00, 1 August 2025 +
IL-01037-02 +
Modification date"Modification date" is a predefined property that corresponds to the date of the last modification of a subject and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
11:20:02, 4 August 2025 +
15:57:00, 11 October 2024 +
18.456 d (442.95 hours, 2.637 weeks, 0.607 months) +
05:00:00, 23 September 2024 +
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