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 found fault codes 78 in conjunction with 112 and 116 indicating the head to base connection was the problem.The fse also found corrosion on the pins at connector.To fix the issue, the fse replaced the connector cable and gasket.Unrelated to the reported issue, the fse replaced the safety disk as it was approaching the expiration due cycle count.The fse then performed leaked checks, full functional checks, electrical safety and safety checks.The iabp passed all functional and safety tests per factory specifications, and was returned to the customer and cleared for clinical use.
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed an ¿internal communication error¿ message.The customer also reported that the iabp unit did not display the battery icon.No patient harm, serious injury or adverse event was reported.
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