The event occurred in india during routine check.It was reported that the hl20 pump displayed the error message: ¿runaway¿.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation and repair on 2023-11-21.The failure could not be replicated.As a preventive measure the tacho strobe was cleaned and all connections and cable were refitted.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.With reference to the hl20 risk management file the most probable root cause could be determined as follows: (un)intended change of pump speed by e.G.: deactivated interventions / override; by knob; by display setting; slave mode (controlled by master).The review of the non-conformities has been performed on 2023-12-05 for the period of 2017-01-31 to 2023-11-20.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 2017-01-31.Based on the results the reported failure "runaway" could not 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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