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 beginning at around 75 minutes into procedure and which fell just under the detection threshold for flagging the platelet product for wbc verification.The signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted 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 and a follow-up report will be provided.
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