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 02/22/2022 |
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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It was reported by a field service agent (fsa) that the pump had a "purge failure" alarm when first put on the patient.As a result, the pump was swapped with another pump.There was no report of patient complication, serious injury, or death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of purge failure alarm is confirmed.Upon receipt of the returned pcs assembly, the inlet fitting was noted broken, which can cause the reported issue.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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It was reported by a field service agent (fsa) that the pump had a "purge failure" alarm when first put on the patient.As a result, the pump was swapped with another pump.There was no report of patient complication, serious injury, or death.
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Search Alerts/Recalls
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