AVANTA FLUID MANAGEMENT SYSTEM

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK REPORT OF THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6), COMPLETED (B)(6) 2025, VERIFIED IT WAS OPERATING WITHIN BAYER SPECIFICATION. THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: "WARNING: EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT." 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 DECEMBER 8, 2011 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.

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A PATIENT WENT INTO CARDIAC ARREST FOLLOWING A LEFT CORONARY ARTERIOGRAM WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6). MEDICAL STAFF SUSPECTED AN AIR INJECTION HAD OCCURRED WHILE THE INJECTOR WAS CONNECTED TO THE PATIENT; HOWEVER, THIS WAS NOT CONFIRMED ON THE FLUOROSCOPIC IMAGES FROM THE PROCEDURE. FOLLOWING THE EVENT, THE PATIENT WAS RESUSCITATED, INTUBATED, AND TRANSFERRED TO THE INTENSIVE CARE UNIT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM, SERIAL NUMBER (B)(6), COMPLETED (B)(6) 2025, VERIFIED IT WAS OPERATING WITHIN BAYER SPECIFICATION. THE MULTI-PATIENT STERILE DISPOSABLE SET (MPAT, LOT NUMBER UNKNOWN) AND THE SINGLE-PATIENT STERILE DISPOSABLE SET (SPAT, LOT NUMBER UNKNOWN) WERE DISCARDED BY THE SITE AND 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 AVANTA FLUID MANAGEMENT SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: DO NOT CONNECT A PATIENT TO THE INJECTOR OR ATTEMPT AN INJECTION UNTIL ALL AIR HAS BEEN REMOVED FROM THE SYRINGE AND FLUID PATH. EXPEL ALL AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, TRANSDUCER, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. BEFORE CONNECTING THE SINGLE-PATIENT DISPOSABLE SET (SPAT) TO THE PATIENT, ENSURE ALL STOPCOCKS AND OPEN PORTS ARE CLOSED TO AIR AND ALL AIR HAS BEEN REMOVED FROM THE FLUID PATH BEFORE INJECTION. IMPROPER MANIPULATION OF THE WASTE PORT STOPCOCK AS WELL AS ANY FLUID PORT LEFT OPEN TO AIR MAY INCREASE THE RISK OF INTRODUCING AIR INTO THE FLUID PATH. DO NOT ATTEMPT TO ASPIRATE FLUID FROM THE HEMODYNAMIC PORT. DOING SO MAY INCREASE THE RISK OF INDUCING AIR INTO THE FLUID PATH. VERIFY THAT THE FLUID PATH IS OPEN AND 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 (B)(6) 2011 WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF (B)(6) 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.

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 40-YEAR-OLD MALE WENT INTO CARDIAC ARREST FOLLOWING A RIGHT CORONARY ARTERIOGRAM WHILE CONNECTED TO A MEDRAD® AVANTA FLUID MANAGEMENT INJECTION SYSTEM (SN (B)(6)). MEDICAL STAFF SUSPECTED AN AIR INJECTION HAD OCCURRED WHILE THE INJECTOR WAS CONNECTED TO THE PATIENT; HOWEVER, THIS WAS NOT CONFIRMED ON THE FLUOROSCOPIC IMAGES FROM THE PROCEDURE. FOLLOWING THE EVENT, THE PATIENT WAS RESUSCITATED, INTUBATED, AND TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS DISCHARGED 7 DAYS LATER AND IS REPORTED AS DOING WELL.