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 03/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
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Event Description
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There was no patient involvement.It was reported by the field service representative (fsr) that the pump alarms with purge failures.As a result, the fsr replaced the pcs, and the pump passed all functional checks.
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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.According to the event details, the customer replaced the pcs assembly.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 risk.This will be monitored for any developing trends.
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Event Description
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There was no patient involvement.It was reported by the field service representative (fsr) that the pump alarms with purge failures.As a result, the fsr replaced the pcs, and the pump passed all functional checks.
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Search Alerts/Recalls
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