Model Number N/A |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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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 evaluate the iabp.The autofill failure 37 "fill fail - iab disconnect".The fse troubleshooting proved during the autofill that k10 failed to isolate pim from atmospheric pressure.The fse replaced the pneumatic module assembly and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per 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 an autofill failure.It is unknown the circumstances under which the 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 an autofill failure.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, e1 (event site email), g4, g7, h2, h6 (evaluation method codes), h10, h11.Corrected fields: h6 (patient codes).
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Search Alerts/Recalls
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