It was reported that hole was found on tyvek during unpacking the product and there was not any damage detected on the outer box (cardboard box).Therefore, the product was not used for treatment.No harm to any person has been reported.The sample investigation is not required at this time.The reported failure is already known by manufacturer and the provided pictures within the complaint show the reported failure clearly.Based on this, the failure could be confirmed.The production history records (dhrs) of the affected be-mecc 101403 with lot# 3000315561 was reviewed on 2022-09-11.According to the dhr results, the product be-mecc 101403 passed the defined manufacturing and final release specifications.Further, quality hold has been initiated for the product ¿be-mecc 101403 / 701075208¿.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.Based on the investigation results, the probable causes have been found as: transport / stationary: unknown transport conditions, manufacture failure: loose velcro strap connection by manufacture employee, design failure: single velcro strap usage is not qualified for the related set therefore velcro strap becomes loose.The detailed root cause analysis will be performed within capa.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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