The product was not requested for manufacturer laboratory investigation as the failure is known and was investigated in a similar complaint.The investigation results of the similar complaint (703006002) are as follows: the product was investigated in the laboratory of the manufacturer with the following outcome: during visual inspection several damages at the outer carton box were detected.Beside of this the tyvek peel cover was forced through.It was also determined that the quadrox's inlay within the tray, which is connected to the trays inner wall by welding spots, was unsoldered.Due to this the blood outlet connector of the unsecured product within the tray was able to force through the tyvek peel cover.This was most probable caused due to excessive physical force during transport.Based on the investigation from the complaint (b)(4), the received picture and the investigation results obtained so far the reported failure could be confirmed.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.Device history record of the complained lot 70115896 has been investigated by qa maquet hechingen and no abnormality was found.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The event has been reported with a delay due to our retrospective examination of the record.At the time ((b)(6) 2017) the complaint was reviewed and found not to be reportable.Current day, we compared the record with equivalent events, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we will report it within capa # (b)(4).
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