Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly the result of a wbc saturation of the lrs chamber which occurred toward the end of the procedure.The signals in the run data file indicate that the device had difficulty maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted at around 65 minutes into the procedure, and could potentially have impacted the collection.Additionally, based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.Investigation is in process, a follow-up report will be provided.
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