Investigation: the disposable set was unavailable for return and investigation.The run data file (rdf) was analyzed for this event.The device history records (dhr) were reviewed for this lot.There were no issues noted in the dhr that would contribute to the elevated wbc count that the customer experienced.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was likely a result of an escape of wbcs from the lrs chamber during a portion of the procedure.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.It also cannot be ruled out that a sampling, calculation, or other process error could have contributed to the higher-than-expected wbc content in the platelet product.
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