Maquet cardiopulmonary (b)(4) has not requested the product for manufacturer laboratory investigation as the failure is already known to the manufacturer and has been investigated under a previous complaint (# (b)(4)).The investigation results of this similar complaint are as follows: maquet cardiopulmonary (b)(4) received the product for investigation.A visual inspection was performed in the laboratory of the manufacturer.Thereby a damaged outer packaging could be confirmed.Furthermore a dhr review was conducted for the lot in question.There was no rework or scrap record performed during production activities.The most probable cause of the failures found is excessive physical force during transport.A trend review was performed.3 similar complaints were found.Due to this no systemic issue could be determined.The failure was detected during incoming inspection.The product was not used for patient treatment.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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