The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as 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.The stm powered up the iabp unit and an autofill failure code #37 was generated.Upon further evaluation, the stm observed bodily contaminate in the pneumatic interface module and in all the tubing lines and modules.The stm replaced the pneumatic module assembly, patient interface module (pim) to backplane cable, filters, clear polyurethane tubing, helium reservior assembly, in-line female pneumatic fitting, pressure-vacuum reservoir, muffler to reservoir fitting, o-ring, and muffler fitting then ran the iabp unit for 72 hours.Subsequently the stm performed preventative maintenance (pm) including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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