It was reported that after 45 minutes of veno-arterial ecmo, a small blood leak is observed through the joint of the oxygenator housing on the side of it close to the arterial outlet.During priming of the set no liquid leak was observed.The hls set was exchanged.On 2024-10-26 the information was received that the patient had a cardiac arrest before connected to the affected product.According to the customer the outcome of the patient was good, the hls set was changed for a new one as a prevention.The affected product was investigated in the getinge laboratory on 2024 (b)(6) with following conclusion: the failure could be confirmed.The root cause for the leakage is a damaged sample line.The production records of the affected product were reviewed on 2023-12-11.According to the final test results, the product passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "leakage due to damaged sample line" could be confirmed.This complaint was found in the database of customer complaints for the hls set as a single event (timeframe from 2022-10-25 till 2023-10-25).The customer will be informed about the results by the getinge sales and service unit.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.
|