The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to evaluate this unit and was unable to reproduce the reported issue.The fse reported that the device iabp fill was responsive and able to execute multiple times.The touch screen calibration and display test was completed and passed successfully.The gas loss alarm was unable to be verified but the event logs shows fill fail/shuttle purge time out multiple times.The fse also re-check gas leaks on both external and internal tanks and both passing within specification.The fse was unable to verify if the helium tank was open or close at the time when customer experienced the problem, but it may be caused of the problem including loose or kinked catheter.Full calibration was re-done again despite that the unit is all within specs.The fse then performed full functionality, performance and safety testing.The iabp was returned to the customer and cleared for clinical use.
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It was reported that while placing a patient on bypass, the cardiosave intra-aortic balloon pump (iabp) was placed on standby to cannulate.After 30 seconds of standby, the customer went back to the iabp unit, and it emitted a ¿gas loss¿ alarm.The iabp would not allow the intra-aortic balloon (iab) to be auto-filled, and the iabp button on the touchscreen was not reacting to 2-5 seconds hold of the button.The iabp was switched out to continue patient therapy, and there was no patient harm or adverse event reported.Subsequently, a getinge representative was able to reproduce the reported issue with the screen but 1 out of 3 times the iab fill worked.The getinge representative tested the touchscreen and the iab fill would work 1 out of 3 times it was attempted.The getinge representative also reported that it could be an issue with the end user as ¿gas loss¿ alarm also should not have occurred after 30 seconds of standby time.
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