It was reported that hole was found on tyvek while preparing the equipment.Therefore, the product was not used for treatment.The pack is quarantined.No harm to any person has been reported.Qh 2023.02 was initiated for the product ¿be-mecc 101403 / 701075208, v04¿.Further, a capa has been initiated for the reported failure ¿hole at tyvek / tyvek perforated¿ and for the reported product ¿be-mecc 101403 / 701075208¿.The root cause analysis and further actions to determine corrective measures for the failure will be performed within the capa.All further steps will be performed in accordance to capa.The production history records (dhrs) of the affected be-mecc 101403 with lot# 3000315701 was also reviewed on 2024-02-12.According to the dhr results, the product be-mecc 101403 passed the defined manufacturing and final release specifications.Based on the results, and provided photographical evidence, the reported failure "hole (perforation) at tyvek" could be confirmed.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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