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 02/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(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 that the pump alarmed purge failure.As a result, the pcs was replaced, and the machine was returned to service.
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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.Dried blood was noted in several internal components which potentially caused the reported alarm.The root cause of how the blood entered the pcs assembly 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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There was no patient involvement.It was reported that the pump alarmed purge failure.As a result, the pcs was replaced, and the machine was returned to service.
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Search Alerts/Recalls
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