Model Number IPN000320 |
Device Problems
Mechanical Problem (1384); Improper Flow or Infusion (2954)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/02/2020 |
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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It was reported that when the intra-aortic balloon pump (iabp) was in use, the staff received high baseline alarms and system error 3.
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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 iabp system error 3 and high baseline alarms are confirmed by the hospital biomed.Blood was noted in the iabp's pneumatic system, which can cause contamination of the pneumatic system resulting in system error 3 and high baseline alarms.The root cause of this complaint is catheter related.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 revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that when the intra-aortic balloon pump (iabp) was in use, the staff received high baseline alarms and system error 3.
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Search Alerts/Recalls
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