The event occurred in the us.It was reported that a hmod 70000-usa #squadrox-id adult o.Filt was placed on a patient and a leakage of clear fluid from the gas exhaust ports was noticed.Not blood only clear fluid was leaking.The customer suspected it is heater/cooler fluid.The oxygenator was replaced with another one during use.No harm to any person has been reported.The affected hmod 70000-usa #squadrox-id adult o.Filt was investigated in the getinge laboratory on 2022-04-27 with the following results: a tightness test of the water, gas and blood side was performed and no abnormalities or leakage are detected.No other abnormalities on the affected oxygenator were noticed.Based on the investigation results the reported failure "leakage gas outlet" could not be confirmed.However, the reported failure "leakage gas outlet" can be linked to the following most possible root causes according to the quadrox-i small adult/adult, quadrox-id adult risk management file: - broken or distorted diffusive fibers.The production records of the affected hmod 70000-usa #squadrox-id adult o.Filt with lot#3000172920 were reviewed on 2022-04-27.According to the final test results, the hmod 70000-usa #squadrox-id adult o.Filt with lot#300020230 and serial number (b)(6) passed the tests as per specifications.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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