White film on arterial side of oxy.Va ecmo commenced on 15 july @noon.White film appeared on 20 july @0340 (was not visualized at 0230 check).Summary of patient condition and ecls management leading up to visualization of film: crrt/cvvh (heparin+normal saline primed circuit) commenced @1245, causing dilutional coagulopathy as seen in 1520 bloodwork.Heparin bolus given and infusion increased, and platelets transfused.Repeat coags showed good heparin effect, but platelets further decreasing with unrecordable fibrinogen: platelets, cryo and ffp given to correct coagulopathy underlying coagulopathy improved, however atiii remains low: antithrombin concentrate given and heparin infusion decreased as per our protocol.Complaint id: (b)(4).
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A similar issue was investigated under complaint#: (b)(4) on 2020-07-30.Results of laboratory investigation: the fibrin film on the arterial side could be confirmed.During visual inspection no defects or foreign bodies which could cause blood clotting were detected.The leak test according to lv 201 and lv 202 did not show any leakages.For further investigation a ct scan of the oxygenator was performed.The ct scan as well showed no abnormalities.In addition a ct scan of two other oxygenators with the same malfunction from the same hospital was performed and no defects were found (refer complaint#: (b)(4).For further investigation one oxygenator with the same failure (complaint#: (b)(4) was send to an external laboratory on 2020-10-20 to analyze the reported film.The result of this analysis was that the blood clot film consists of a dense fibrin network with enclosed erythrocytes and platelets.A medical review was performed by manager medical affairs on 2020-08-19.Results of medical review: as stated in the complaint reports, the customer observed the formation of a milky-white clot in the be-hmod 30000 post-chamber (arterial side) a number of days after initiating extracorporeal support using the product.While the user(s) indicated that a number of clinical parameters showed little to no deviation from the institution¿s clinical practice and/or protocol, some points are of particular interest with respect to this report.These are the following: it was mentioned that protamine was administered during extracorporeal support to reduce the activated clotting time (act) from 400 seconds to 200 seconds.While this does not appear to be a clinical regularity for this institution, it may have been a precipitating event, resulting in the observation cited by the customer in at least one case.Normal antithrombin iii (atiii) levels for children are between 60-90%.The complaint report mentioned that the atiii levels were maintained at 21% to reduce the bleeding experienced by the patient.A study in 2014 held atiii levels at 70% of normal for patients on ecmo using supplementation.An average activated partial thromboplastin time (aptt) of 42 seconds was stated by the customer.The usual therapeutic target for aptt is 1.5 ¿ 2.5x (60-80 seconds) the normal aptt with heparin.According to the customer transexamic acid was administered to a patient in one case.Transexamic acid is a known antifibrinolitic and is usually administered to manage a defined coagulopathy.Last, while the administration of blood products during ecmo are frequently necessary, blood products containing procoagulative elements (e.G.Platelets) may serve to accelerate the coagulation cascade, resulting in unexpected results in the extracorporeal circuit.Any one, or a combination, of the above mentioned points may have contributed to the phenomenon observed in the context of this complaint.Thus the reported failure can be confirmed but it was no product related malfunction.A review was performed on 2020-11-18 and 14 complaints from the same hospital (b)(6), australia) were received for the same failure.In all cases no product related malfunction could be confirmed.The ssu agreed with the customer to update their anticoagulation policy and trial this for the next 10 cases then review the incidence of this film forming.They admitted that their anticoagulation is not adequate for the management of patients on ecmo.No additional complaint was received since then.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.
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