AVANTA FLUID MANAGEMENT SYSTEM

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT OCCURRED WHILE A PATIENT WAS CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). IT WAS REPORTED THAT DURING THE FIRST INJECTION OF THE PROCEDURE, AIR WAS VISUALIZED IN THE LEFT CORONARY ARTERY. THE PATIENT WAS REPORTED TO HAVE BEEN ADMITTED TO THE INTENSIVE CARE UNIT. THE CUSTOMER HAS STATED THAT NO FURTHER INFORMATION REGARDING THE INCIDENT WILL BE PROVIDED TO BAYER; THEREFORE, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SERIAL NUMBER (B)(6)) WAS COMPLETED ON (B)(6) 2025 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MULTI-PATIENT STERILE DISPOSABLE SET (MPAT) AND THE SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT) IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE. THE LOT NUMBERS WERE NOT PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS PROVIDED ON (B)(6) 2025. 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. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS JANUARY 12, 2016, WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF SEPTEMBER 24, 2016, FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT YET REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME.