Maquet cardiopulmonary gmbh was requested the product back for investigation on 2019-09-11.Quadrox-i adult was received on 2019-09-23.Biological residuals were observed on the sample and therefore the device was submitted to a cleaning process using sodium hypochlorite as per local procedure lv 205.After the cleaning process, the device was submitted to a visual test and leaking test.In visual inspection, no identifiable defect was found.The leaking test on the blood side connection of the device was performed on 2019-10-23 according to test method lv 201 and a leakage from the dialysis lock and valve was detected.Therefore the reported failure could be confirmed.Maquet cardiopulmonary gmbh has been already initiated a capa based on several complaints showing the same symptoms with different material numbers than the one in this complaint, in order to determine the root cause and initiate further actions to determine corrective measures for the failure.All further steps will be performed in accordance to capa.The reported failure was identified as part of the current risk management file (dms# (b)(4)) and the most possible root cause is associated to wrong design.Mitigation for this specific failure is in place per design specification: the dialysis lock connector and corresponding components of the quadrox-i-id small adult/adult shall be of appropriate dimension to enable a stable and non leaking connection.There is an engineering change request regarding design change of dialysis-valve to improve the sealing properties of the dialysis-valve.In addition the device history record for complaint 245706 and lot 70128438 and 922560369 have been reviewed.There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.The reported failure did not contribute to death or serious injury.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.
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