(b)(4).Maquet cardiopulmonary (b)(4) will not be able to investigate the product as it will not be available for manufacturer's investigation for the complaint #(b)(4), because contaminated set was throwed away by hospital.On the other hand,4 sets were available for investigation, and the product was received for evaluation under complaint #(b)(4).Based on this investigation, the filter has been inspected visually and it was found that the filter has been installed incorrectly.Additionally, the received complaint has been investigated by maquet cardiopulmonary (b)(4).Thereby a device history record of the reported lot has been investigated and no abnormality was found.Based on the received picture the reported failure could be confirmed by maquet (b)(4).The most probable cause was determined as a assembly failure caused by an operator mistake.As a corrective action a training has been performed with the explanation of the assembly of the filter.Furthermore the operators of maquet (b)(4) have been informed about the complaint.Additionally, a review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.
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