It was reported that the delta pressure increased.The hls set was exchanged during treatment.No harm to any person has been reported.The affected product was not available for technical investigation of the manufacturer as it was discarded by the customer.Thus it was not possible to determine the exact root cause of the reported event.However the failure mode "delta p increased" can be linked to the following most possible root causes according to the risk management file hls set advanced: - deteriorating gas transfer.- blockage of oxygenator.- damage of gas fibers.- malfunction of oxygenator.- too low anticoagulation.- too low at level, effect of heparin is too limited.- protamine sulfate enters the hls set.- thrombozytopenia.The production records of the affected hls module (batch #3000160656 ) were reviewed on 2022-05-05.Following steps are performed according to the bop with a 100 % inspection: following tests are performed according to the bop as a 100 % inspection: * pressure test heat exchanger.* leak test water/gas side.* pressure test blood side.* final functional test.According to the final test results, the hls module with the serial#(b)(6) passed the tests as per specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Based on the above mentioned investigation results the reported failure "delta p increase" could not be confirmed.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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