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 06/01/2020 |
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 the intra-aortic balloon pump (iabp) repeatedly alarmed for "possible helium leakage".The staff attempted to adjust the intra-aortic balloon (iab) position and reducing the balloon volume, but the alarm persisted.The problem was solved after the iab was replaced.The second 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).Teleflex received the device for investigation.The reported complaint of iab helium loss alarm is not confirmed.The returned intra-aortic balloon catheter (iabc) bladder was fully intact with no abnormalities noted.The returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.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) repeatedly alarmed for "possible helium leakage".The staff attempted to adjust the intra-aortic balloon (iab) position and reducing the balloon volume, but the alarm persisted.The problem was solved after the iab was replaced.The second iab was inserted 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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