The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to investigate and found a leak in the fill manifold and disconnect fitting.The stm replaced the o-ring, helium tubing and fill manifold; then performed all calibration, functional and safety tests per factory specifications.The iabp was returned to the customer and cleared for clinical service.
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