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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 03/24/2022 |
Event Type
malfunction
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Event Description
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There was no patient involvement.It was reported by the clinical support specialist (css) that during training, the pump had persistent purge failure alarms.The pump powered on with no difficulty and the pump was connected to the electronic simulator and balloon-in-tube properly.The pump would attempt to begin pumping when the pump "on" button was pressed; however, it would not get past the first purge attempt without issuing the alarm.There was helium available, and the valve was open.The balloon connector was connected, and the pump showed a trigger acceptance.As a result, the pump was sent to biomed.
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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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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 alarms is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the serial number/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 by the clinical support specialist (css) that during training, the pump had persistent purge failure alarms.The pump powered on with no difficulty and the pump was connected to the electronic simulator and balloon-in-tube properly.The pump would attempt to begin pumping when the pump "on" button was pressed; however, it would not get past the first purge attempt without issuing the alarm.There was helium available, and the valve was open.The balloon connector was connected, and the pump showed a trigger acceptance.As a result, the pump was sent to biomed.
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Search Alerts/Recalls
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