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: a definitive root cause for the observed leukoreduction failure remains undetermined at this time.The analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content reported in the rbc product for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trimaaccel system operated as intended.Based on the available information, it is possible that the filter was unloaded from the filter bracket and loaded again during rbc collection or rbc additive solution addition, which could have a similar affect to ¿squeezing¿ the filter when using a gravity drain system.It is also possible that the reported results could be attributed to an issue with the filter.
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