Investigation: the disposable set was unavailable for return and evaluation.The run data file (rdf) was analyzed for this event.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.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 in the platelet product reported for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Based on the available information, it cannot be ruled out that the reported results 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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