The event occurred in the us.It was reported that the delta p pressure in the hls set climbed higher and higher.No clots were noticed.The hls set was replaced during treatment with no consequences to the patient.No harm to any person has been reported.The affected beq-hls 7050 usa#hls set advanced 7.0 with lot# 3000171768 was investigated in the getinge laboratory on 2022-01-18 with the following results: during the investigation of the beq-hls module with lot#3000163290 the reported failure "delta p pressure increased" could not be confirmed.No abnormalities could be detected, which would indicate a defect within the hls module.Based on the investigation results, the reported failure "delta p increased" could not be confirmed.However the failure mode "delta p increased" can be linked to the following most possible root causes according to our risk management file (dms#1468452).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 affected beq-hls module with serial number (b)(6) was reviewed on 2022-01-21 and according to the final test results, the beq-hls module passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.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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