It was reported that a small amount of blood leaks from the de-airing port on the blood inlet side of oxygenator during extracorporeal circulation.The de-airing port was not closed by protection cap during extracorporeal circulation.The product was not replaced due to the leakage and was discarded by user facility.The affected product was not available for technical investigation of the manufacturer as it was discarded by the hospital.A review for similar complaints was performed and no similar complaint was found.The production records of the affected production lot (dms# (b)(4) were reviewed on 2021-07-15.According to the final test results, all oxygenators passed the tests as per specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Thus it was not possible to determine the exact root cause of the reported event.Thus the reported failure could not be confirmed.According to the risk assessment quadrox-i (dms#(b)(4) pressure exceeding the tightness level of de-airing port could led to a damage of the de-airing membrane and therefore a blood leakage could occur (risk id r2.2.4).This could be a most probable cause of the reported 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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