TRIMA ACCEL ENHANCED PLT, PLS, RBC SET

Additional Manufacturer Narrative

(B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD WAS REVIEWED. NOTHING WAS FOUND THAT WAS RELATED TO THIS EVENT. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. POSSIBLE ROOT CAUSES WERE PROVIDED IN THE INITIAL REPORT FOR THIS EVENT. AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF ELEVATED WBC COUNTS.

Description of Event or Problem

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 PT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PT INFO IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(4). THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

Additional Manufacturer Narrative

(B)(4). INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE ANALYSIS FO THE RDF DID NOT FIND A CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED AND THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. BASED ON THE AVAILABLE INFO, IT IS POSSIBLE THAT THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT COULD BE DONOR RELATED. IT ALSO CANNOT BE RULED OUT THAT A SAMPLING OR OTHER PROCESS ERROR MAY HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.