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Model Number IPN000262 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2021 |
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 the intra-aortic balloon pump (iabp) gave frequent high pressure alarms.The staff tried troubleshooting by straightening the pipeline, injecting air into the balloon with a large needle, reducing the balloon volume to 20cc, and adjusting the counterpulsation ration to 1:2 but the alarm still continued to appear.As a result, the intra-aortic balloon (iab) was replaced.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 report complaint of iab high pressure alarm is confirmed.During the investigation, a kink was noted to the outer lumen and numerous kinks were noted to the iabc.Upon functional testing, the pump alarmed for "high pressure" and the cause of the alarm is a result of the kinked/damaged outer lumen.The root cause of the complaint is undetermined, but a potential cause is customer handling.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 risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) gave frequent high pressure alarms.The staff tried troubleshooting by straightening the pipeline, injecting air into the balloon with a large needle, reducing the balloon volume to 20cc, and adjusting the counterpulsation ration to 1:2 but the alarm still continued to appear.As a result, the intra-aortic balloon (iab) was replaced.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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