Model Number IPN001112 |
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 04/18/2022 |
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 the clinical support specialist (css) that the pump has multiple "purge failure" alarms.As a result, the staff swapped to a second pump with no difficulty.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 "persistent purge failure" was confirmed by the field service agent.According to the service report, the pump assembly was replaced due to blood backup.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 revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported by the clinical support specialist (css) that the pump has multiple "purge failure" alarms.As a result, the staff swapped to a second pump with no difficulty.There was no report of patient complications, serious injury, or death.
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Search Alerts/Recalls
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