This report is being filed to provide additional information.Investigation: one red blood cell bag without the filter from the collection set was returned for evaluation.The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found.Shipping testing was performed on the reserve samples from the reported lot number.There serve samples were also visually examined and the solution volume and solution composition were tested with no abnormalities noted.Root cause: a definitive root cause for the observed elevated wbc count remains undetermined at this time.Based on the available information, an increase of wbc contamination complaints were noted from the previous lot number, further investigation was performed.Investigation results indicated that the cause of higher-than-expected wbc content in the whole blood product was due to the maximum pore size of the filter membranes likely to increase according to the combination of multiple parameters in manufacture ofleuko reduction filter membranes and wbc contamination is likely to occur frequently in the product lots of which the maximum pore size of the filter membrane has increased.The instructions for use provide a caution to not squeeze or apply pressure to the filter while it is attached to the bag containing the filtered blood in order to avoid leukocyte leakage.Corrective action: an internal capa has been initiated to review the combination of the multiple parameters suggested the tendency of the increase in the maximum pore size of the filter membrane.Manufacturing specifications were updated to narrow the range of the parameters in manufacture of filter membranes and it was confirmed that the appropriate level of the maximum pore size of the filter membrane was achieved.
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