Catalog Number IAP-0700 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 06/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).For complaint related to the same patient and event see mdr #3010532612-2019-00219 and tc # (b)(4).
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) pump shut off suddenly, unknown cause.The machine cycled power out and the pump did not start fast enough and then received a purge failure alarm.As a result, the pump was swapped out.The rn reported that the patient's bp dropped transiently when this occurred.The field service engineer could not reproduce symptom.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) pump shut off suddenly, unknown cause.The machine cycled power out and the pump did not start fast enough and then received a purge failure alarm.As a result, the pump was swapped out.The rn reported that the patient's bp dropped transiently when this occurred.The field service engineer could not reproduce symptom.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4) for complaint related to the same patient and event see mdr #3010532612-2019-00219 and tc #(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "purge failure alarm" is not able to be confirmed.The field service engineer checked the pump and could not replicate the problem.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial 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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Search Alerts/Recalls
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