The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp unit and was unable to reproduce the reported "autotfill failure" issue.The fse initiated autofill using a test balloon and a simulator, and the iabp unit functioned normally.The fault log indicated "autofill failure 7" preceded by "leak in iab circuit," suggesting that the catheter or catheter extender was not fully connected.The fse then performed all pneumatic, functional and safety checks to meet factory specifications.Unit passed all pneumatic, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
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