It was reported that the delta pressure was increased during use.The set was replaced with no harm to the patient.The patient was infected with covid-19.The affected hls module with lot#3000164491 was investigated in the getinge laboratory on 2022-04-05 with the following results.During the investigation no abnormalities were detected.Further no leakage or functional issues of the pump could be confirmed.The investigated hls module worked according to its specifications.The patient was infected with covid-19.As stated by the getinge medical affairs team and in reference to the literature [1] 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 is a result of a combination of processes driven by the disease occurring in synergy with the effect of the extracorporeal circuit on the coagulation system.[1] with reference to the risk assessment hls set advanced 5.0 / hls set advanced 7.0, dms#1468452, v26 and in consultation with the manager medical affairs the following events can contribute to the reported failure: - 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.The production records of the affected hls module (batch #3000164491 ) were reviewed on 2022-04-06.Following steps are performed according to the bop with a 100 % inspection: following tests are performed according to the bop as a 100 % inspection: * pressure test heat exchanger; * leak test water/gas side; * pressure test blood side; * final functional test.According to the final test results, the hls module with the serial#(b)(6) passed the tests as per specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Based on the investigation results the reported failure "delta pressure increased" could be confirmed, but not product related malfunction.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.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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