IMUGARD

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 WHOLE BLOOD PRODUCT. PER THE CUSTOMER, THEIR REVIEW OF THE RUN LOG SHOWED THERE WERE NO ERRORS WITH THE CORRESPONDING PLATELETS THAT WERE IN THE POOL. THEY ALSO PERFORMED A VISUAL INSPECTION OF THE FILTER THAT WAS USED DURING THE PLATELET POOLING PROCESS AND THERE WERE NO ABNORMALITIES OBSERVED. 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.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN D.4, H.6 AND H.11. INVESTIGATION: A USED PLATELET POOLING ASSEMBLY WAS RETURNED FOR INVESTIGATION. IT WAS NOTED THAT THE FILTER HAD CLUMPING AND CLOTTING THROUGHOUT. THE FILTER WAS FLOW TESTED AND PASSED. THE FLUID WAS ABLE TO FLOW FREELY THROUGH THE FILTER ASSEMBLY. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND NO OTHER REPORT FOR SIMILAR ISSUES ON THIS LOT. 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. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THIS COMPLAINT. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT IS LIKELY DUE TO ONE OR A COMBINATION OF THE POSSIBLE CAUSES LISTED BELOW: * VARIATION IN MANUAL EXPRESSION STEPS OF THE PLATELET PRODUCTION PROCESS * THE FILTER HOUSING AND/OR MEMBRANE IS PHYSICALLY DAMAGED * DONOR PHYSIOLOGY

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B5, D9, H3, H6 AND H11. INVESTIGATION: A USED PLATELET POOLING ASSEMBLY WAS RETURNED FOR INVESTIGATION. IT WAS NOTED THAT THE FILTER HAD CLUMPING AND CLOTTING THROUGHOUT. THE FILTER WAS FLOW TESTED AND PASSED. THE FLUID WAS ABLE TO FLOW FREELY THROUGH THE FILTER ASSEMBLY. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND NO OTHER REPORT FOR SIMILAR ISSUES ON THIS LOT. 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. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.

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 WHOLE BLOOD PRODUCT. PER THE CUSTOMER, THEIR REVIEW OF THE RUN LOG SHOWED THERE WERE NO ERRORS WITH THE CORRESPONDING PLATELETS THAT WERE IN THE POOL. THEY ALSO PERFORMED A VISUAL INSPECTION OF THE FILTER THAT WAS USED DURING THE PLATELET POOLING PROCESS AND THERE WERE NO ABNORMALITIES OBSERVED. 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.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.

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 WHOLE BLOOD PRODUCT. PER THE CUSTOMER, THEIR REVIEW OF THE RUN LOG SHOWED THERE WERE NO ERRORS WITH THE CORRESPONDING PLATELETS THAT WERE IN THE POOL. THEY ALSO PERFORMED A VISUAL INSPECTION OF THE FILTER THAT WAS USED DURING THE PLATELET POOLING PROCESS AND THERE WERE NO ABNORMALITIES OBSERVED. 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. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION.