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Catalog Number IAB-S840C |
Device Problems
Device Alarm System (1012); Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) alarmed more than ten minutes later after insertion, indicating helium leak.There was blood in the three bifurcate.Processing according to the standard, the fault still existed while the catheter worked normally after replacing with a new one.Patient outcome reported as fine.There was no report of patient death, serious injury or complications.
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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 functional testing, a crack was found at the injection site of the iab bifurcate for the central lumen.This crack allowed a leak to occur at the injection site of the central lumen.The root cause of how the crack occurred 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 revised risks.This will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) alarmed more than ten minutes later after insertion, indicating helium leak.There was blood in the three bifurcate.Processing according to the standard, the fault still existed while the catheter worked normally after replacing with a new one.Patient outcome reported as fine.There was no report of patient death, serious injury or complications.
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Search Alerts/Recalls
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