(b)(4).Investigation: per the customer, the units were processed and the alleged hemolysis was observed in the plasma post centrifugation.The disposable set was not returned for evaluation.The manufacturing records, and testing and inspection records were reviewed for this lot.No anomalies were noted and the product conformed to current established specifications.Similar reports have been received regarding this production lot number.Three retention samples from this production number were visually examined.One bag was tested for solution volume and the other two were tested for the composition of the solution.There were no abnormalities in appearance and measured values conformed to in-house standards.Investigation of the manufacturing change control history for the past two years, confirmed that the specification for the cationizing agent had been increased.This change had been implemented, to allow greater stability in production.Hemolysis testing was performed to investigate the impact of the cationizing agent.Investigation results indicate that the cationization level of the filter which was integrated into the sterilized product increased and the concentration of free hemoglobin in whole blood increased.The distribution width of the cationization level of actual filters were reviewed and found that it was possible that the width of the cationization level of actual filters is causing the hemolysis control method of the average cationization level was changed to a new control method.Root cause: the following root causes were determined: as a result of the increase in the amount of the cationizing agent, the cationization level of the filter which was integrated into the sterilized product, increased.The distribution width of the average cationization level of the combination of filter membranes was wide and showed some filter membranes of which the average cationization level was high.Corrective action: the following corrective actions were implemented: the amount of the cationizing agent was restored to the previous manufacturing specifications.A new filter control method was created, and the control criteria of the average cationization levels was reduced.
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The customer reported that they had one unit of plasma derived from whole blood with a red-tinge they believe is due to hemolysis.There was not a transfusion recipient or patient involved at the time of whole blood processing, therefore no patient information is reasonably known at the time of the event.Donor #: (b)(6), the disposable set is not available for return because it was discarded by the customer.
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