MEDRAD® STELLANT FLEX CT INJECTION SYSTEM WITH CERTEGRA® WORKSTATION

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER: (B)(6) WAS COMPLETED ON (B)(6) 2026, BY A BAYER SERVICE REPRESENTATIVE, WHO CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. THE INJECTOR SYSTEM HAS REMAINED IN DAILY USE SINCE THE REPORTED OCCURRENCE. THE CUSTOMER DECLINED THE OFFER OF ADDITIONAL APPLICATIONS TRAINING. THE DISPOSABLES UTILIZED DURING THE REPORTED EVENT WERE DISCARDED BY THE SITE, AND THE ASSOCIATED LOT NUMBERS WERE NOT PROVIDED; THEREFORE, RETAINED SAMPLE TESTING COULD NOT BE PERFORMED. THE MEDRAD® STELLANT FLEX INJECTION SYSTEM OPERATION MANUAL INCLUDES THE FOLLOWING WARNING: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. CAREFULLY READ THE INSTRUCTIONS FOR LOADING AND THE USE OF THE SYRINGE BEACON AND MEDRAD® FLUIDOTS (WHERE APPLICABLE) TO REDUCE THE CHANCE OF AIR EMBOLISM. THE PRESENCE OF A SYRINGE BEACON OR ROUNDED FLUIDOTS DOES NOT INDICATE THE TOTAL ABSENCE OF AIR BUBBLES IN THE SYRINGE TIP. FLUIDOTS MUST BE VIEWED IN A PROPERLY ILLUMINATED ENVIRONMENT WITH A LIGHT SOURCE BEHIND THE OPERATOR PROVIDING ENOUGH LIGHT TO PERMIT EASY VIEWING. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. TO MINIMIZE THE POSSIBILITY OF INADVERTENT ASPIRATION AND INJECTION, ENSURE THE PATIENT IS DISCONNECTED FROM THE INJECTOR WHEN UTILIZING THE FORWARD AND REVERSE PISTON CONTROLS THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

BAYER MEDICAL CARE INC. BECAME AWARE ON JULY 10, 2026, OF AN ALLEGED AIR EMBOLISM FOLLOWING A CT EXAMINATION IN WHICH CONTRAST MEDIA WAS ADMINISTERED USING A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM. THE EVENT INVOLVED A 57-YEAR-OLD MALE PATIENT WITH AN ADMITTING DIAGNOSIS OF A RENAL MASS. AT THE CONCLUSION OF THE EXAMINATION, THE PATIENT WAS REPORTEDLY ASYMPTOMATIC AND DISCHARGED HOME. APPROXIMATELY THREE HOURS AFTER THE PROCEDURE, A RADIOLOGIST REPORTEDLY IDENTIFIED A MODERATE-TO-LARGE AIR EMBOLISM ON THE ACQUIRED CT IMAGES, WITH AIR VISUALIZED WITHIN THE VENOUS VASCULATURE, RIGHT HEART, AND PULMONARY TRUNK. THE RADIOLOGY REPORT NOTED THAT THESE FINDINGS WERE PRESENT ONLY ON THE POST-CONTRAST IMAGES. FOLLOWING REVIEW OF THESE FINDINGS, THE PATIENT WAS CONTACTED AND ASKED TO RETURN TO THE EMERGENCY DEPARTMENT FOR EVALUATION. SUBSEQUENT CT IMAGING REPORTEDLY DEMONSTRATED RESOLUTION OF THE AIR EMBOLISM, AND NO ADDITIONAL TREATMENT WAS REQUIRED.