It was reported that hospital received a pack with with a hole on the tyvek cover.After opening and inspecting the tray they found out that the oxygenator was not at it's place and the oxygenator holder was broken.The product was not requested for investigation since the photographs are sufficient to confirm the failure attached to the parent record.The photographs were reviewed and reported failure ' a hole on the tyvek and broken insert' could be confirmed.It was also reported within this complaint that there is no outer pack damages.The device history record for lot #92302824 was reviewed on 2021-05-09.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.According to the support document sd-80 rev0, there is 100% visual inspection according to 6 eye principle for tyvek lid.Device history record review shows that this control was performed.It could be conclude that the device was manufactured in compliance with defined production steps and specifications.Appropriate manufacturing documentation and production step controls were in place.In addition to this according to operation procedure basic operation procedure 9201233 rev1 packing tubing set inside trays is performed according to the technical drawing or picture instructions.Based on the information above, no manufacturing problem was found.However, the reported failure a hole on the tyvek cover could be confirmed.The reported failure was identified current risk management file (dms# 1906296, v19), risk ids h1.2.2, h1.2.4, h1.2.6.The most probable cause is associated with transport of the product -product dropped on the floor-.A review of the risk assessment (dms# 1906296, v19) was performed on 2021-05-09, the reported failure is covered in risk ids h1.2.2 (infection), h1.2.4 (infection), h1.2.6 (injury of patient).The threshold for risk acceptability for risk ids h1.2.2 (infection), h1.2.4 (infection), h1.2.6 (injury of patient) has been defined as ptotal = 2 in the risk assessment (dms# 1906296, v19).The occurrence rate of ptotal = ¿2:seldom' corresponds to n = 0,000462761 according to the risk management plan tubing sets (dms # 1964868, v9).The reported 3 complaints (review period from 2020-04-13 until 2021-04-13) is applicable to (b)(4) devices sold.This corresponds to an occurrence rate 0,000077582 = 0,000462761, which is below the acceptance threshold according risk management plan (dms # 1964868, v9).There were no complaints reported, which were associated with serious injury or death within the reviewed period.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.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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