CLEARLINK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO B3, D10, H4, H6, AND H11: H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

B3: EVENT DATE: THIS EVENT OCCURRED IN AUGUST 2025. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET HAD FLOW ISSUES DURING PATIENT INFUSION. THE SET UNDERINFUSED THE BLOOD TRANSFUSION WITH PRBC (PACKED RED BLOOD CELLS). THE EXPECTED THERAPY TIME WAS 4 HOURS, BUT THE BAG WAS ONLY APPROXIMATELY HALF EMPTY. THE CLAMP FOR NORMAL SALINE WAS CLOSED, BUT THE NORMAL SALINE BAG WAS MORE THAN HALF EMPTY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.