Catalog Number IAB-05840-LWS |
Device Problems
Device Alarm System (1012); Failure to Unfold or Unwrap (1669)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: for related complaint see mdr #1219856-2017-00316 and tc #(b)(4).
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Event Description
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It was reported by the rn that a second intra-aortic balloon (iab) was easily inserted and went to standby and on.The rn told the clinical support specialist (css) that the iab still would not unwrap.The rn tried again and said it "seems to be working now" but the pump started to alarm again.The rn commented to the md that it must be the patient.The md decided to remove the catheter and that the patient was stable.There were no reported patient complications and no reported patient death or serious injury.No medical intervention was required.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint that the balloon did not unwrap properly is not confirmed.Although, the root cause of the complaint remains undetermined the device passed all functional testing.The iab was pump tested and no alarms occurred.No further action required.For related complaint see mdr #1219856-2017-00316 and tc # (b)(4).
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Event Description
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It was reported by the rn that a second intra-aortic balloon (iab) was easily inserted and went to standby and on.The rn told the clinical support specialist (css) that the iab still would not unwrap.The rn tried again and said it "seems to be working now" but the pump started to alarm again.The rn commented to the md that it must be the patient.The md decided to remove the catheter and that the patient was stable.There were no reported patient complications and no reported patient death or serious injury.No medical intervention was required.
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Search Alerts/Recalls
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