It was reported that the sterile barrier was broken.Holes were found on tyvek and therefore, the product was not used for treatment.No harm to any person has been reported.The sample was investigated at maquet cardiopulmonary gmbh laboratory on 2023-09-07.Visual inspection was performed.According to the visual inspection, it is concluded that the extra shipping box is damaged from the outer side and it is observed that there is stress topside of the box.It means that the box is most likely fallen upside down or another box placed onto it.Besides, similar damages were also observed on the lateral side of the white box and tray.These damages on the white box and shipping box could be related to the transport.Moreover, a visual inspection of the tyvek and protective carton showed that the protective carton had damages that were very close to the area where the holes occurred on tyvek.The tyvek seal was opened and it was confirmed that the holes on the tyvek are at the quadrox-ir venous probe attachments area.Further, the insert of the quadrox-ir was stable and fixed however the hole of the insert where the velcrostrap was assembled was broken.The velcro strap was in a loose condition and quadrox-ir was able to move and was not fixed.It was also observed that the venous probe attachment of quadrox-ir was damaged.The possible damage on tyvek is caused by the venous probe attachment¿s obstructing object while quadrox-ir is moving vertically.Furthermore, since the distance between tyvek and the quadrox-ir is about 2 cm, the vertical movement of the quadrox-ir has a high degree of damage possibility.Based on the investigation results, the failure could be confirmed.The production history records (dhrs) of the affected be-mecc 101403 with lot# 3000315561 was reviewed on 2022-09-04.According to the dhr results, the product be-mecc 101403 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.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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