As the product in question is contaminated with the coronavirus sars-cov-2, it was not requested to be returned by the customer due to the high risk of spreading the virus.Therefore no laboratory investigation could be performed by the manufacturer.The product in question was produced in 2020-03.The review of the non-conformities during the period of 2020-03-01 to 2020-11-23 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.A review for similar complaints with a relating laboratory investigation was performed on 2020-11-17 with the following outcome: results of laboratory investigation complaint #: (b)(4); as the tubing was not available for investigation only the hls oxygenator was investigated.During optical inspection no visible defects were detected.The leak test performed according to lv 201 (blood side) did not reveal any leakage.The oxygenator worked according to its specifications.A product related malfunction was not confirmed during investigation of complaint #: (b)(4).For complaint #: (b)(4), it was reported that the crrt circuit was recently changed on the morning of the same day.According to the ifu it is possible that air enters the oxygenator if the following measures were not followed: ifu hls set 1.5 / g-270 /02,using dialysis lock warning!: if a tube is connected to the dialysis lock with valve during ongoing perfusion, air may enter the oxygenator.This can lead to an air embolism in the patient.Screw the tube to the dialysis lock with a swift turn-and-press movement.Make sure that the tube is not clamped and the air in the tube is displaced by the blood flowing out, to prevent a pulsating backflow of air into the oxygenator.Make sure that the pressure in the oxygenator is higher than the ambient pressure.Thus the most probable cause of the reported event could be air entering the hls module during exchange of the crrt circuit after 4 days of support on this circuit, which triggers the arterial bubble sensor.Thus the reported failure could be confirmed but was most probable not caused by a product related malfunction.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the event.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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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Details: (b)(6)- year old male; diagnosis: covid/ards supported on peripheral vv ecmo ¿ issue occurred on day 4 of support on this circuit ¿ crrt (hemofiltration) was connected to both apical ports of the hls oxygenator.During morning of day 4 ¿art bubble detect¿ alarm was triggered, support ceased and return line clamped.Circuit inspected and small amount of air visualized on arterial side of oxygenator at apical point.It was noted that the crrt circuit was recently changed that morning also.Patient ventilation support was maximised whilst ecmo support suspended ¿ circuit was changed out with no ill effect to patient and support resumed.The patient was weaned off ecmo successfully the next day, and did not suffer any detriment due to the issue in question.Customer would like the hls module inspected to see if there was a product failing that enabled air to enter the module/circuit.Complaint id: (b)(4).
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