Further investigation steps are performed on 2022-07-26 in the getinge laboratory with the following results: the additional information were provided in the investigation of the cardiohelp involved in the event (mcp ref.600744).A getinge service technician (fst) was sent for investigation on 2022-03-10 and recognized that the pump disposable error was found to be due to a misdetection of the hls set.According to the cardiohelp risk file following root causes can lead to the reported failure: occlusion in the disposable, no or insufficient coupling between the cardiohelp and the hls set, magnetic coupling disturbed.Based on these investigation results the reported failure could be confirmed, but the exact root cause could not be determined, since the investigated hls module was fully functional.The production records of the affected hls module were reviewed on 2022-06-24.Following tests are performed according to the bop as a 100 % inspection: pressure test heat exchanger, leak test water/gas side, pressure test blood side, final functional test.According to the final test results, the hls module with lot number 3000182956 and serial number (b)(6) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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