Model Number IPN000320 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).Other remarks: see mdr# 3010532612-2020-00400 (tc 1900081771) as the report is related to the same patient.
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Event Description
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It was reported that when the intra-aortic balloon pump (iabp) was swapped out with the new iabp the staff experienced a purge failure alarm.As a result, the staff was able to get a third iabp, which connected and started pumping without issue.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of purge failure alarm is not able to be confirmed.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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00400 (tc 1900081771) as the report is related to the same patient.
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Event Description
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It was reported that when the intra-aortic balloon pump (iabp) was swapped out with the new iabp the staff experienced a purge failure alarm.As a result, the staff was able to get a third iabp, which connected and started pumping without issue.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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