The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.White blood cell (wbc) count is not available at this time.The platelet collection 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 an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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This report is being filed to provide additional information.Investigation: 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.During customer follow-up, it was confirmed that the wbc count was below <5x10^6.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The run data file (rdf) was analyzed for this event.Root cause: analysis of the run data file showed that the collection of platelets was unstable during the course of the procedure, possibly caused by the multiple flow adjustments.Throughout the procedure, the draw flow was adjusted downwards 16 times and upwards 30 times, while the return flow was lowered 7 times and readjusted upwards 8 times.Due to the flow adjustments made along the procedure, the flow through the lrs chamber was modified multiple times.It is possible, though not conclusive that wbcs may have exited the lrs chamber throughout the procedure.Based on the available information, it is also possible that this leukoreduction failure is donor related.
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