Model Number IPN000320 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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There was no patient involvement.It was reported that purge failure was detected during preventative maintenance.The iabp has not been used for a long time as the hospital was covid 19 converted.The pcs was replaced and the pump returned to service.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "purge failure alarm" is confirmed.The release spring inside the vent valve was found stuck which was the result of the alarm.The root cause of how to release spring became stuck 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 that purge failure was detected during preventative maintenance.The iabp has not been used for a long time as the hospital was covid 19 converted.The pcs was replaced and the pump returned to service.
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Search Alerts/Recalls
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