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Catalog Number IAP-0700 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/09/2019 |
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 the intra-aortic balloon pump (iabp) had a system error 3 alarm, 30-minutes after starting up.A power cycle was made on the iabp to resume pumping, but the iabp continued to alarm.As a result, the iabp was switched out.The iabp was sent to biomed for a functional check.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).The reported complaint of "system error 3 alarm" is confirmed based on the picture of the recorder strips provided in the complaint and the fluid on the cpm board found by the field service engineer during the service of the pump; however, no parts were returned to teleflex for investigation.The root cause of how the fluid got inside the pump is undetermined.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 revised risks.This will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) had a system error 3 alarm, 30-minutes after starting up.A power cycle was made on the iabp to resume pumping, but the iabp continued to alarm.As a result, the iabp was switched out.The iabp was sent to biomed for a functional check.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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