AVANTA FLUID MANAGEMENT SYSTEM

Description of Event or Problem

THE FOLLOWING INFORMATION WAS REPORTED TO BAYER. A PATIENT WAS UNDERGOING A CORONARY ANGIOGRAM WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SERIAL NUMBER (B)(6). DURING THE FIRST INJECTION OF CONTRAST, AIR WAS VISUALIZED ON THE DISPLAYED IMAGES AFTER WHICH NON-SPECIFIED EMERGENCY TREATMENT WAS IMMEDIATELY INITIATED, AND CARDIOPULMONARY RESUSCITATION (CPR) / ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) WAS PERFORMED BY THE MEDICAL TEAM. DESPITE THESE EFFORTS, THE PATIENT COULD NOT BE RESUSCITATED AND CEASED TO BREATHE.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM (SERIAL NUMBER (B)(6) WAS COMPLETED ON OCTOBER 6, 2025, AT WHICH TIME THE EQUIPMENT WAS CONFIRMED TO BE OPERATING TO SPECIFICATION. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS WAS DECLINED BY THE CUSTOMER. THE MEDRAD® AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: MINIMIZING AIR EMBOLIZATION RISKS: 1. WARNING: DO NOT INJECT AIR · AIR EMBOLISM HAZARD: INJURY OR DEATH CAN RESULT. · OBSERVE CHANGES IN FLUIDOTS® INDICATORS, FOR MEDRAD® SYRINGES. · EXPEL AIR FROM SYRINGE/DISPOSABLES. - READ OPERATION MANUAL. 2. DO NOT CONNECT A PATIENT TO THE INJECTOR OR ATTEMPT AN INJECTION UNTIL ALL AIR HAS BEEN REMOVED FROM THE SYRINGE AND FLUID PATH. 3. EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. CAREFULLY READ THE INSTRUCTIONS FOR LOADING AND THE USE OF FLUIDOTS® INDICATORS (WHERE APPLICABLE) TO REDUCE THE CHANCE OF AIR EMBOLISM. 4. DISCONNECT THE PATIENT FROM THE AVANTA SINGLE-PATIENT DISPOSABLE SET (SPAT) IF A SYSTEM MALFUNCTION OCCURS. 5. VERIFY THAT THE FLUID PATH IS FREE OF AIR BEFORE ATTEMPTING AN INJECTION. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.