This report is being filed to provide additional information.The whole blood collection set was not available for return for evaluation.The manufacturing, testing, and inspection records were reviewed for this lot.No anomalies were noted and the product conformed to current established specifications.Root cause: a definitive root cause for the observed elevated wbc count remains undetermined at this time.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the whole blood product could be donor-related(characteristics of blood).It also cannot be ruled out that a filtering error or other process error(not resting the collected blood prior to filtering; not expressing air properly from the product bag) could have contributed to the higher-than-expected wbc content in the whole blood product.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 and to clamp the blood filled tubing before the blood enters the filter in order to avoid leukocyte leakage.
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