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Model Number N/A |
Device Problems
Inability to Auto-Fill (1044); Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The full event site name is (b)(6).The getinge field service engineer (fse) that encountered the issue was unable to reproduce the reported issue during service.However, upon reviewing the cs300 intra-aortic balloon pump (iabp) unit logs, the fse verified that the unit had a autofill failure and leak in the iab circuit messages.The fse determined that the issue was likely caused by the balloon, or balloon connections.To fix the issue, the fse replaced the safety disk and the unit was allowed to operate for an extended period of time without any issue.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.
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Event Description
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It was reported that the customer requested repair service for the cs300 intra-aortic balloon pump (iabp) unit in relation to an unspecified issue.After a getinge field service engineer (fse) evaluated the unit, it was further reported that the iabp unit had an autofill failure & leak in iab circuit messages.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 customer requested repair service for the cs300 intra-aortic balloon pump (iabp) unit in relation to an unspecified issue.After a getinge field service engineer (fse) evaluated the unit, it was further reported that the iabp unit had an autofill failure & leak in iab circuit messages.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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Search Alerts/Recalls
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