FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

Description of Event or Problem

THIS INCIDENT IS RELATED TO THE SAME PATIENT REPORTED IN MDR 3004548776-2026-00296. ON (B)(6) 2026, 02:30 PM FOLLOWING COMPLETE CLINICAL STABILIZATION, TPE WAS RE-ATTEMPTED. TO EVALUATE THE POSSIBILITY OF ALBUMIN-RELATED HYPERSENSITIVITY, FRESH FROZEN PLASMA (FFP) WAS USED AS REPLACEMENT FLUID INSTEAD OF ALBUMIN. APPROXIMATELY 20 MINUTES AFTER INITIATION OF THE PROCEDURE, AFTER TRANSFUSION OF ONE FFP UNIT AND DURING ADMINISTRATION OF THE SECOND FFP UNIT, THE PATIENT AGAIN DEVELOPED A SEVERE HYPERSENSITIVITY REACTION WITH CUTANEOUS MANIFESTATIONS AND SIGNIFICANT HYPOTENSION. THE PROCEDURE WAS IMMEDIATELY DISCONTINUED, AND APPROPRIATE EMERGENCY MANAGEMENT WAS INSTITUTED. PRIOR TO THE SECOND TPE PROCEDURE, THE PATIENT RECEIVED A SLOW TRIAL INFUSION OF ALBUMIN FROM AN ALTERNATIVE MANUFACTURER WITHOUT ANY ADVERSE REACTION. A SEPARATE FFP EXPOSURE OUTSIDE THE TPE PROCEDURE RESULTED ONLY IN A MILD DELAYED RASH OVER THE THIGH APPROXIMATELY TWO HOURS LATER, WITHOUT RESPIRATORY COMPROMISE OR HEMODYNAMIC INSTABILITY.