ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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Model Number IPN000254 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that there was a helium loss alarm and blood was noted in the intra-aortic balloon (iab) gas drive line.The intra-aortic balloon pump (iabp) was turned off, iab disconnected (no blood back up to iabp), tubing clamped, and doctor notified.As a result, the iab was removed and a new iab was inserted using the same insertion site.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that there was a helium loss alarm and blood was noted in the intra-aortic balloon (iab) gas drive line.The intra-aortic balloon pump (iabp) was turned off, iab disconnected (no blood back up to iabp), tubing clamped, and doctor notified.As a result, the iab was removed and a new iab was inserted using the same insertion site.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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