Model Number IPN001112 |
Device Problems
Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Information (3190)
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Event Date 07/30/2020 |
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 a purge failure alarm and blood backed into the system.As a result, the iabp was swapped out.There was no information provided regarding the patient outcome.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) gave a purge failure alarm and blood backed into the system.As a result, the iabp was swapped out.There was no information provided regarding the patient outcome.
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Manufacturer Narrative
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(b)(4).No iabp parts were returned to teleflex chelmsford for investigation.The reported complaint of the purge failure alarm is confirmed.The field service engineer found blood inside the pump, which is likely the cause of the alarm.The field service engineer replaced all contaminated parts.The root cause of the complaint is undetermined.Blood can only enter the iabp from an iab that develops a leak.The ifu states: "intra-aortic balloon membrane perforation may occur during iabp therapy.The occurrence and severity of the iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation.Large perforations are rare.Small perforations can result in asymptomatic release of gas.Perforation can cause blood to appear in the balloon catheter and driveline tubing." 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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Search Alerts/Recalls
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