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Model Number IPN000320 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2021 |
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 staff got a purge failure alarm.The staff had exchanged the helium tank and driveline tubing prior to calling.As a result, the pump was swapped out.There was no report of patient complication, serious injury, or death.
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Event Description
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It was reported that the staff got a purge failure alarm.The staff had exchanged the helium tank and driveline tubing prior to calling.As a result, the pump was swapped out.There was no report of patient complication, serious injury, or death.
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Manufacturer Narrative
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Qn#(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.The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers of ac2's at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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