FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

Description of Event or Problem

ON (B)(6) 2026, 10:00 AM, A THERAPEUTIC PLASMA EXCHANGE WAS INITIATED USING THE COM.TEC SYSTEM WITH 5% ALBUMIN (PLASMAGEN®) AS REPLACEMENT FLUID. APPROXIMATELY 15 MINUTES AFTER INITIATION OF THE PROCEDURE, THE PATIENT DEVELOPED A SEVERE HYPERSENSITIVITY/ANAPHYLACTOID REACTION CHARACTERIZED BY WHEEZING, STRIDOR, OXYGEN DESATURATION, GENERALIZED URTICARIA/HIVES, FLUSHING, FACIAL PUFFINESS, TACHYCARDIA, AND SEVERE HYPOTENSION (BLOOD PRESSURE DECREASED FROM APPROXIMATELY 140/90 MMHG TO 80/60 MMHG). THE PROCEDURE WAS IMMEDIATELY DISCONTINUED. THE PATIENT WAS TREATED WITH ADRENALINE 0.1 MG, HYDROCORTISONE 100 MG IV, PHENIRAMINE MALEATE (AVIL®) 1 AMPOULE IV AND GELOFUSINE® 500 ML BOLUS. SUPPLEMENTAL OXYGEN VIA FACE MASK. THE PATIENT SUBSEQUENTLY STABILIZED.