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 service territory manager (stm) was dispatched to evaluate the iabp and determined that the autofill failure flush fill timeout was the issue.To fix the issue, the stm calibrated the fill management and the to get the unit back into spec.The iabp passed full calibration, safety, and functionality checks to factory specifications.The unit was returned to the customer and cleared for clinical use.
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