Catalog Number IAP-0700 |
Device Problems
No Device Output (1435); Pumping Stopped (1503)
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Patient Problems
Arrhythmia (1721); Death (1802); No Consequences Or Impact To Patient (2199)
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Event Date 12/31/2018 |
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 the intra-aortic balloon pump (iabp) suddenly stopped without any alarm even when ecg readings were available.The pump stopped twice as a result, the pump had to be reset.There was a report of patient death.Dr.(b)(6) made the medical judgement that the patient's death was not caused or contributed by the device.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation.The reported complaint of iabp would not start pumping is not confirmed.A certified technician inspected the pump and no functional issues were noted.The root cause of the complaint 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.The reported complaint 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) suddenly stopped without any alarm even when ecg readings were available.The pump stopped twice as a result, the pump had to be reset.There was a report of patient death.Dr.(b)(6) made the medical judgement that the patient's death was not caused or contributed by the device.
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Search Alerts/Recalls
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