IMUGARD

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. 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. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND THREE (3) TOTAL REPORTS (INCLUDING THIS EVENT) FOR SIMILAR ISSUES ON THIS LOT. SEE MDRS: 1722028-2025-00096 AND 1722028-2025-00095. 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.

Description of Event or Problem

THE CUSTOMER REPORTED ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN A WHOLE BLOOD DERIVED PLATELET PRODUCT. (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE UNIT PROCESSING; THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN D.4, H.6 AND H.11. 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. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND THREE (3) TOTAL REPORTS (INCLUDING THIS EVENT) FOR SIMILAR ISSUES ON THIS LOT. SEE MDRS: 1722028-2025-00096 AND 1722028-2025-00095. FURTHER EVENTS ARE BEING REVIEWED FOR REPORTABILITY AND WILL BE FILED AS REQUIRED INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.

Description of Event or Problem

THE CUSTOMER REPORTED ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN A WHOLE BLOOD DERIVED PLATELET PRODUCT. DONOR UNIT ID#: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE UNIT PROCESSING; THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN A WHOLE BLOOD DERIVED PLATELET PRODUCT. DONOR UNIT ID #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE UNIT PROCESSING; THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.