The initial failure description was that the rotaflow "flow has been interrupted".A getinge service technician was onsite to test the affected rotaflow.The technician was unable to reproduce the reported failure, but stated that there might have been a kinked tube or movement.The device is working as intended.The most probable root cause could be determined as a kinked tube or movement.Based on these investigation results the reported failure could be confirmed but no product related malfunction has been found.The product in question was produced in 2018-05-15.The review of the non-conformities has been performed on 2021-06-23 for the period of 2018-05-15 to 2021-06-23.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 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.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.
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