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 the facility.The stm evaluated the iabp and was able to reproduce the reported issue.To resolve the issue, the stm attempted to adjust the transducers, but it was subsequently decided to replace both the drive and shuttle transducer.In addition, the stm also replaced the luer plug, and then performed all functional and safety checks which passed per factory specifications.The iabp was returned to the customer and cleared for clinical service.Full name of the event site: (b)(6) cath lab.
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