Thrombosis on the venous side of the oxygenator after 28 hours of use was reported.The reported failure was already investigated in complaint #(b)(4) with the following outcome: during cleaning according to lv 205 revealed massive contamination in oxygenator 1.Oxygenator 1 was so heavily clotted that a low water flow was only possible with a very high pressure increase.Oxygenator 1 was then cleaned with sodium hydrochloride.This process was repeated 7 times, resulting in the cleaning of this oxy over several days.Oxygenator 2 was only slightly contaminated.No clots could be detected.The leak test of the water side according to lv 202 showed no pressure drop in both oxygenators.The leak test of the blood side according to lv 201 showed a pressure drop of approx.¿p=0.4 bar after 300 minutes for oxygenator 1 and 2.No water leakage could be observed from the oxygenators on the blood side during both leak tests.With reference to the risk assessment quadrox-id pediatric, dms # 1462367, v18) 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.Debris formation (clogging) at the inlet fiber structure of the oxygenator.Hemodynamic impairment.Hemostasis.Insufficient anticoagulation, occlusion of the extracorporeal circulation.Act too low for specific procedure and patient condition.The production records of the affected quadrox-id päd.O.Filt.(dms# (b)(4) and dms #(b)(4)) were reviewed on 2021-01-19.Following tests are performed according to the bop as a 100 % inspection: ¿ leak test after welding.¿ pressure test heat exchanger.¿ leak test water side.¿ leak and flow test gas side.¿ pressure test blood side.¿ coating test.According to the final test results, the oxygenator passed the test as per specifications.Production related influences can be excluded.Based on this the reported failure could be confirmed but no product related malfunction.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident 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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