TRIMA ACCELL ENHANCED PLT, PLS, RBC SET

Description of Event or Problem

THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WBC CONTENT THAT WAS MEASURED IN THE PLATELET PRODUCT COLLECTION. THERE WAS NOT A TRANSFUSION RECIPIENT OR PT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL TESTING, THEREFORE NO PT INFO IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT#: (B)(6). THE DISPOSABLE KIT WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

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: 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. NOTE: THIS REPORT SHOULD HAVE BEEN SUBMITTED AS SUPPLEMENT 1, HOWEVER, 1722028-2011-00271 SUPPLEMENT 1 WAS INADVERTENTLY ELECTRONICALLY SUBMITTED AS 1722028-2012-00271 SUPPLEMENT 1. THEREFORE, THIS REPORT IS BEING SUBMITTED AS 1722028-2012-00271 SUPPLEMENT 2, EVEN THOUGH IT IS ACTUALLY THE FIRST SUPPLEMENT.

Additional Manufacturer Narrative

(B)(4). THE ANALYSIS OF THE RUN DATA FILE (RDF) DID NOT INDICATE 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, CALCULATION, 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 FOLLOW UP REPORT WILL BE PROVIDED.

Additional Manufacturer Narrative

(B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. 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.