Model Number IPN001112 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/03/2021 |
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 intra-aortic balloon pump (iabp) had a consistent system error #3 alarm while on patient.As a result, the iabp was switched out quickly without issues.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "system error 3" is confirmed.An excessive noise was noted from the pump assembly consistent with a lead screw malfunction.The system failed to find the home position, which is likely the cause of the alarm.The root cause of how the leadscrew and bellow became disengage 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 revived risk.This will be monitored for any developing trends.
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Event Description
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It was reported that intra-aortic balloon pump (iabp) had a consistent system error #3 alarm while on patient.As a result, the iabp was switched out quickly without issues.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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