This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: the set in question was not returned for investigation.We therefore conducted investigations based on the provided information.In regard to the production of imuflex, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.For the leukoreduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.We reviewed the manufacturing record of the reported lot number and confirmed that no anomalies occurred in any process, and the products were manufactured as usual.In addition, we investigated dope material used for the reported lot number and found that the viscosity of pu solution of dope material conformed to the standards.Release testing, which includes measurements of solution concentration and volume and a visual inspection, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the production number and confirmed that there were no anomalies in all release testing items.The product conformed to the standards.Regarding the retained sample of the reported lot number, three sets were visually examined.There were no abnormalities in their appearances.We used one of the sets to measure the solution volume and used another one of the sets to perform a quantitative test for the composition of the solution in the same manner as the release testing.The measured results conformed to our in-house standards.Regarding the reported lot number, we reviewed whether there had been any complaints reported by other customers.The results revealed that complaints against wbc contamination associated with this lot number had not been reported by any other customers as of july 16, 2020.Root cause: we reviewed the manufacturing record and the testing and inspection record of the reported lot number; however, we did not find any abnormalities and we were not able to identify the cause of the issue.
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