It was reported that the venting -de airing- membrane of the oxygenator was leaking small amounts of blood during perfusion.It was decided not to change and replace the oxygenator.No harm to patient was reported.The product was investigated in the laboratory of manufacturer on 2021-09-17.Visual inspection and leak test were performed.The visual inspection of the oxygenator showed no signs of damage.The blood-side leakage test showed leakage as dripping when the luer cap is unscrewed the de-airing membrane of oxygenator, at a pressure of 1.5 bar.Based on this failure could be confirmed.Based on the investigation results, the following most probable root causes could have contribute to the leakage at de-airing membrane: inadequate stamping membrane, inadequate welding vent membrane, inadequate adhesive application and curing connectors.Device history record for lot number 70134051 was reviewed on 2021-06-09.Following tests are performed according to the basic operation procedure (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 with the serial# (b)(6) passed the tests as per specifications.The occurrence rate was calculated for the reported failure and product 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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The product was investigated in the laboratory of manufacturer on 2021-07-26.Visual inspection and leak test were performed.The blood-side leakage test showed leakage as dripping when the luer cap is unscrewed the de-airing membrane of oxygenator, at a pressure of 1.5 bar.Device history record for lot number 70134051 was reviewed.Following tests are performed according to the basic operation procedure (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 with the serial# (b)(6) passed the tests as per specifications.Production related influences are unlikely.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The root cause analysis is ongoing.
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