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 field service engineer (fse) went to the site to evaluate the iabp and reported that he found bad o-ring at the cart/pump connection.The fse replaced the o-ring and this corrected the leak issue.The fse performed full calibration, functional testing and safety check to factory specifications; unit passed and was returned to customer and cleared for clinical use.
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