The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp unit and ran the unit thru service manual instructed leak tests, all tests were good except when helium tank was shut off the system leaked down.The fse disassembled the unit and the cart , tightened all connections from the 300 psi check valve back to the helium tank mount, found a loose fitting that connected to the helium tank mount, after reassembling the cart and console, the fse performed a complete helium leak test, complete calibration and functionality tests, the unit passed all test.The iabp was returned to the customer and cleared for clinical use.
|