Catalog Number IAB-05840-LWS |
Device Problems
Device Alarm System (1012); No Device Output (1435); Obstruction of Flow (2423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/27/2018 |
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 insertion of the intra-aortic balloon (iab), the staff noted they had no pressure waveform and were receiving high pressure alarms.The perfusionist had decreased the volume, but the pump continued to have alarms.As a result, the iab was removed and a second iab was inserted.The second iab was inserted without difficulty and is functioning appropriately.There was no report of patient complication or serious injury and death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of iab high pressure alarm is not confirmed.The returned iab was fully intact with no bends, kinks or damage noted.Although, the root cause of the complaint is undetermined the returned device passed visual and functional test specifications.No further action required at this time.
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Event Description
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It was reported that after insertion of the intra-aortic balloon (iab), the staff noted they had no pressure waveform and were receiving high pressure alarms.The perfusionist had decreased the volume, but the pump continued to have alarms.As a result, the iab was removed and a second iab was inserted.The second iab was inserted without difficulty and is functioning appropriately.There was no report of patient complication or serious injury and death.
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Search Alerts/Recalls
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