Model Number IPN000257 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 01/31/2021 |
Event Type
Injury
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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 the intra-aortic balloon pump (iabp) alarmed, and blood was noted in the helium chamber of the intra-aortic balloon (iab).As a result, dr.Ye faming immediately removed the iab and re-inserted a new iab catheter at a different insertion site.There was no report of patient complications or death.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.The iabc central lumen was noted broken in the flex tip assembly area, which can cause blood to enter the helium pathway.The cause of the central lumen break could not be confidently determined, but a potential cause is forceful handling of the device.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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Event Description
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It was reported that the intra-aortic balloon pump (iabp) alarmed, and blood was noted in the helium chamber of the intra-aortic balloon (iab).As a result, dr.Ye faming immediately removed the iab and re-inserted a new iab catheter at a different insertion site.There was no report of patient complications or death.
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Search Alerts/Recalls
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