Model Number N/A |
Device Problem
Leak/Splash (1354)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and discovered fluid build-up insides the pneumatic module which caused a k10 failure and error 37 "fill fail-shuttle purge." to fix the issue, the fse replaced the pneumatic module assembly, and then performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had a fluid leak and also required safety disk replacement.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had a fluid leak and also required safety disk replacement.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Search Alerts/Recalls
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