Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A lot history review was performed.There was one other complaint reported against this lot.The complaint addresses a dialyzer blood leak (no sample).A review of the production record was performed.The production record review showed there was one approved temporary dn in the production of this lot.The dn is unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.There is no recall associated with this complaint.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas (vision systems) and (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
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