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 bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.(b)(6).The 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.
|
This report is being filed to provide additional information in relevant tests/lab data, pma #, evaluation codes, additional mfr narrative, and corrected information in occupation.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 elevated wbc count remains undetermined at this time.The rdf analysis did not show a conclusive root cause for the reported higher than expected wbc count for this collection.It is possible that the pressure alerts and adjustments may have impacted the steady state of the leukocyte reduction chamber and contributed to the reported contamination.It is also possible, though not conclusive, this leukoreduction failure may be donor related.
|