It was reported that the silicone pump boot of the neonatal bypass set (lot: 92262611) had a split in it that was only noticed during cardiopulmonary bypass when it started leaking.The affected product was investigated in the laboratory of the manufacturer on 2021-04-08.Based on the test result it can be confirmed that there is a hole in the tubing section, which leads to blood leakage.Further, it could be determined that modifications on the tubings and cable ties were performed by the customer.The affected section is not in accordance with specification the technical drawing.The exact root cause could not be determined.However, the hole might have been accidentally caused by the customer during the modification.The technical drawing had already been revised on (b)(6) 2019 based on the customer demand, before the complaint was received.Device history record for lot: 92262611 was reviewed on 2021-01-07.There are no evidences indicating non-conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Production-related influences can be excluded.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.Based on the investigation so far, the failure could be confirmed.However, the exact root cause could not be identified.The most probable root cause was determined as user error.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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