Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The run data file (rdf) was analyzed for this event.Root cause : the rdf analysis did not show a conclusive root cause for the higher-than-expected wbc content in the platelet product reported for this collection.Review of the rdf showed a slight delay of cells exiting the lrs chamber at the start of platelet collection.Once the platelets started to exit the lrs chamber, they were collected at the expected platelet concentration.It is possible though not conclusive that the draw pressure too low alerts, which occurred just after the start of the platelet collection, in combination with the flow adjustments temporarily disrupted the steady state of the lrs chamber, causing some wbcs to escape.It cannot be ruled out that this leuko reduction failure is donor related.
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