The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the apheresis platelet product.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6) platelet collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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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.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Rdf analysis determined that the machine operated as intended by flagging the run to alert the operator to verify the wbc count in the platelet product.Root cause: a definitive root cause for the observed leukoreduction failure remains undetermined at this time, however, the system message to verify wbcs in the platelet product was displayed because the trima accel device operated as intended and detected wbcs escaping from the leukoreduction system chamber.The rdf analysis did not show a conclusive root cause for the higher- than-expected wbc content of the platelet.There were no events (adjustments, changes in pump speed, etc.) during the collection that could have cause wbcs to escape from the lrs chamber.Based on the available information, it is possible that this elevated wbc count is donor related.
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