Maquet gmbh requested the product for investigation in the laboratory of the manufacturer.2018-06-13: the product was investigated in the laboratory of the manufacturer with the following outcome: when delivered, still original packed, beq-hls 7050 usa # hls set advanced 7.0 was carried out on the outer packaging and on the inner packaging, a visual inspection was performed.The results of the investigation were documented in writing and figuratively.During the visual inspection of the returned set, various transport damages (holes, dents) were found on the outer packaging.The inner packaging (tray) has no damage except the hole in the tyvekcover.After opening the tyvekcover, it became apparent that the welded inlet to the tray had come off.The oxygenator fixed in the insert can thus move upwards towards the tyvekcover and has pushed a hole in the tyvekcover with the catch on the blood inlet connector and thus interrupted the sterility of the set.Due to this the blood 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.Thus the reported failure could be confirmed.A trend review was performed.20 similar complaints were found.Due to this no systemic issue could be determined.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) 2018) 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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