It was reported that the error message ¿safety-s" was displayed on a hl20 pump.The event occurred during a routine check.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2024-04-03.After the power was cut off, the pump was taken out for inspection and reinstalled, which solved the failure.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.After the power was cut off, the pump was taken out for inspection and reinstalled, which solved the failure.A similar event was assessed by getinge life cycle engineering on 2023-04-18 with the following outcome: it is plausible that the disconnection and reconnection of a component did solve the reported failure.If there was a contact problem (e.G.Due to corrosion of the contacts), it can be rectified by removing and reinserting the component.The most probable root cause is therefore a contamination of the contacts through corrosion.The review of the non-conformities has been performed on 2024-04-17 for the period of 2009-04-01 to 2024-03-18.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2009-04-01.Based on the results the reported failure "error message safety-s" could be confirmed.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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