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Model Number IPN001112 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that system error 3 alarm occurred while on patient.As a result, the intra-aortic balloon pump (iabp) was swapped out.There was no report of patient complications, serious injury or death.Biomed also stated constant tone alarm and iabp shutting off occurred while testing in biomed.Fsa found system error 3/high baseline alarm after pumping for 2 minutes.Replacing the pump assembly fixed the high baseline alarm.Fsa could not replicate constant tone alarm and pump shutting off.Performed functional checklist, iabp performed to spec.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline alarm" is confirmed.The pump alarmed a high baseline during the complaint investigation.An excessive noise was noted from the pump assembly consistent with a motor/lead screw malfunction.The root cause of this complaint is undetermined.No further action required at this time.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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It was reported that system error 3 alarm occurred while on patient.As a result, the intra-aortic balloon pump (iabp) was swapped out.There was no report of patient complications, serious injury or death.Biomed also stated constant tone alarm and iabp shutting off occurred while testing in biomed.Fsa found system error 3/high baseline alarm after pumping for 2 minutes.Replacing the pump assembly fixed the high baseline alarm.Fsa could not replicate constant tone alarm and pump shutting off.Performed functional checklist, iabp performed to spec.
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Search Alerts/Recalls
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