It was reported that the oxygenation performance of a quadrox-id was low during treatment.The quadrox-id was discarded by the customer, thus no technical investigation could be performed.However following probable root causes were already identified in the risk assessment quadrox-id adult: - specification of requirements for extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen and removal of carbon dioxide not met - insufficient flushing - leaks or damage to the oxygenator.Further it was stated that the patient was infected with covid-19.As stated by the getinge medical affairs team and in reference to available literature covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.The increased risk of thrombosis and coagulopathy in ecmo patients may be the result of a combination of processes driven by covid-19 occurring in synergy with the known effect(s) of the extracorporeal circuit on the coagulation system.Clot formation in an extracorporeal circuit can lead to a reduction and/or blockage, and thus, an reduction of the diffusion path lowering the gas transfer performance.Based on the investigation results the reported failure "low performance" could be confirmed.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.Reference: [1] yusuff h, zochios v, brodie d."thrombosis and coagulopathy in covid-19 patients requiring extracorporeal membrane oxygenation" asaio j.2020;66(8):844-846.Doi:10.1097/mat.0000000000001208.
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