Investigation: 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: the run data file did not show a conclusive root cause for the higher-than-expected wbc content in the platelet product reported for this collection.Alerts that could contribute to wbc contamination of the platelet product, such as ¿centrifuge pressure high¿ or ¿rbc spillover¿, were not generated in this run data file.As the rbc detector cannot count the cells passing by, in order to generate a ¿potential wbc contamination detected¿ message, the rbc detector signals must see a significant change in the reflectance values.In this case, the rbc detector reflectance signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.It is possible, though not conclusive, that this leukoreduction failure may be donor related.
|