The review of the non-conformities till 2020-11-13 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 can be excluded.The patient was infected with covid-19.Covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.A similar case was already investigated under complaint#(b)(4) on 2020-06-05: as stated in the investigation report of (b)(4) clots could be found inside the oxygenator.The most probable root cause for the increased pressure drop are clots in the oxygenator leading to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.With reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v24) and in consultation with the manager medical affairs the following events can contribute to clotting in the circuit: -de-airing luer lock connection too loose ; -air remains in or enters the circuit; -hemostasis ; -air or blood remains in luer lock access port; -too low anticoagulation; -too low at level, effect of heparin is too limited ; -protamine sulfate enters the hls set; -administration of substitution of congealable substance such as plateles; -(consumption) coagulopathy; -thrombozytopenia.Based on this the reported failure could be confirmed.The occurrence rate was calculated for the reported failure 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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