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Model Number IPN000263 |
Device Problems
Material Puncture/Hole (1504); Gas/Air Leak (2946)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/20/2020 |
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 after the intra-aortic balloon (iab) was implanted; the intra-aortic balloon pump (iabp) alarmed for "helium leak".As a result, the iab was removed and a new iab was used, 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).Teleflex received the device for investigation.The reported complaint of iab leak suspected is confirmed.During the investigation, a puncture to the bladder, consistent with contact from a sharp object, was found near the distal end of the bladder membrane which caused the helium loss alarm and could allow blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the bladder leak is undetermined, but a potential cause of how the catheter came into contact with a sharp object is customer handling.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 after the intra-aortic balloon (iab) was implanted; the intra-aortic balloon pump (iabp) alarmed for "helium leak".As a result, the iab was removed and a new iab was used, using the same insertion site.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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