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.The getinge fse that discovered the issue replaced the helium reservoir assembly which corrected the problem.The iabp unit passed all calibration, functional and safety tests that were performed and was then returned to the customer and cleared for clinical use.The initial reporter named is a getinge employee who has different contact details from that of the event site.Please refer to the following email and phone (b)(6).
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