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.The getinge stm that discovered t he issue replaced the drive manifold to resolve the issue and then completed pm and all safety, functionality, and calibration checks.All tests passed to factory specifications and the iabp unit was cleared for clinical use and released to the customer.(b)(6).
|
It was reported that during preventative maintenance (pm) performed by a getinge service territory manager (stm), the cs300 intra-aortic balloon pump (iabp) experienced a drive manifold failure during testing of the k6, k7, and k8 solenoids.There was no patient involvement and no adverse event was reported.
|