It was reported that there were cracks in the plastic exterior of the oxygenator.The failure occurred during treatment.On 2023-02-07 the information was received that the hls set was further used on the patient without any malfunction or leakage.The hls set was discarded by the customer, therefore no technical investigation could be performed.However, another hls set with a similar failure was investigated by the getinge laboratory on 2023-05-26 with following conclusion: the visual inspection was performed but cracks could not be confirmed, instead of that these were identified as flow lines.A leak test was performed to confirm the flow lines, thus no leakage could be detected.The reported failure crack in the clear plastic of the oxygenator could not be confirmed.A further hls set was complained as a crack, but was also identified as flow lines.According to the instruction for use (ifu, hls set advanced 6.0/7.0, hit set advanced 5.0/7.0) it is stated in chapter 6.1 ¿preparation and installation¿ that the user should perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fissures.The production records of the hls set were reviewed on 2023-05-31.According to the final test results, all hls modules passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "cracks in the clear plastic of the oxygenator" could not be confirmed.This complaint was found in the database of customer complaints for the hls set as a single event (timeframe from 2022-02-01 till 2023-02-01).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.H3 other text : hls set was discarded by customer.
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