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.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.
|
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.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.
|
Investigation: 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: alerts that are known to contribute to wbc contamination were not generated in these procedures.As the trima system cannot count the cells entering the platelet product bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In these procedures, signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data files reported that the platelet products could be labeled as leukoreduced.Although the trima system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima system.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet products reported for these collections.Based on the available information, it is possible these failures may be related to donor specific blood characteristics that may challenge the trima leukoreduction system, including, but not limited to higher than average donor bmi and/or pre-mnc/pre-wbc counts.It is also possible, though not conclusive, the following may have contributed to the elevated wbc content in the platelet products reported for these collections: inaccurate donor precounts entered plasma line air block or occlusion.
|