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The event occurred in (b)(6).The following was reported: "ecmo circuit be-hls 7050 used for a patient and found plasma leak from 12th day." the oxygenation came down and delta p was rising.The hls set was replaced with another one with no concequences for the patient.The patient was infected with covid 19.No harm to any person has been reported.The affected be-hls 7050 #shls set advanced 7.0 was scrapped due to covid 19 by the customer therefore, a technical investigation could not be performed at the getinge laboratory.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.In the absence of data and based on covid-19 as the most probable root cause for the reported failure, 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.With reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v26) and in consultation with the getinge manager medical affairs team the following events can contribute to clotting in the circuit: air remains in or enters the circuit (not for long run incidents), inappropriately low, or no blood flow, in the circuit, improper hemostasis, too low anticoagulation, too low act level, effect of heparin is too limited, protamine sulfate enters the hls set, administration of congealable substances (such as platelets) or pro-coagulant medications.(consumption) coagulopathy.Getinge medical experts performed a medical assessment on (b)(6) 2021 for a previous event with plasma leakage: plasma leakage from hollow fiber oxygenators and in diffusion membranes have been extensively reported in the literature and is particularly common during long term support and in association with extracorporeal membrane oxygenation [1,2].The variables that have been identified to potentiate plasma leakage include the presence of endogenous (excess lipoproteins, or cholesterol) or exogenous (alcohol, or drugs).These surface acting species in the patient¿s blood may strongly and rapidly modify the hydrophobic character and the intrinsic resistance to plasma breakthrough [3].Authors have also reported i) the duration of application, ii) the administration of pharmacological agents (propafol infusion or agents with a high lipid load), iii) various disease states that alter the total protein component of the blood (and iv) as a result of hyperbilirubinemia [4,5].In this instance the patient was reported to have covid 19 and the reported event took place within 24 hours of treatment initiation.Various cautions and warnings during application are noted in the instructions for use.The hydrophobic de-airing filter integrated into the oxygenator functions as part of the de-airing port process during priming.It can undergo ¿plasma wetting¿ when in contact with blood.The most likely cause is related to bi-polar phospholipids in blood adhering to the surface of the filter.The hydrophobic filter is thus coated with a hydrophilic layer on the filter surface, degrading performance and creating pathways for plasma diffusion and the observed leakage.This change in filter performance has been referred to as a loss of hydrophobicity 5.Based on the investigation results the reported failure "plasma leakage and oxygenation came down and delta p was rising" could be confirmed, but not product related malfunction.The production records of the affected be-015703112 #shls module advanced adult with packaging lot#3000197934 and 3000197942 were reviewed on 2022-04-26 and according to the final test results, all be-015703112 #shls module advanced adult passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.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 [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.References for plasma leakage: heide j.Eash, heather m.Jones, brack g.Hattler, and william j.Federspeil.Evaluation of plasma resistant hollow fiber membranes for.S.L.: asaio, 2004, asaio journal 2004, s.491-497.John m.Daniel, iv philip a.Bernard, sean c.Skinner, prasad bhandary ana ruzic.Hollow fiber oxygenator composition has a significant impact on failure rates in neonates on extracorporeal membrane oxygenation: a retrospective analysis.2018, j pediatr intensive care , s.7:7-13.Gionata fragomeni, mara terzini, antonio comite and gerardo catapano.Blood, the maximal pore size of hydrophobic microporous membranes does not fully characterize the resistance to plasma breakthrough of membrane devices for extracorporeal blood extracorporeal.2020, frontiers in bioengineering and biotechnology.Mc gill, k o¿shaughnessy and j dittmer case report: a paediatric ecmo case of plasma leakage through a polymethylpentene oxygenator.2015, perfusion, s.1-4.Ohshimo, shinichiro.Rapid-onset plasma leakage of extracorporeal oxygenation membranes.Hiroshima, japan : journal of artificial organs, 2018.
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