MEDRAD® MARK 7 ARTERION INJECTION SYSTEM

Description of Event or Problem

MARK 7 ARTERION INJECTOR IS INTEGRATED WITH BIPLANE IMAGING EQUIPMENT. ON [REDACTED], STAFF IDENTIFIED THAT THE INJECTOR WAS NOT FUNCTIONING CORRECTLY. THEY INDICATED THEY RECEIVED ISSUES WITH THE CONTRAST POWER INJECTOR NOT ¿COMMUNICATING¿ WITH THE BIPLANE IMAGING EQUIPMENT. AN ERROR CODE WAS DISPLAYED ON THE DEVICE, 3016. BAYER/MEDRAD WAS ENGAGED ON [REDACTED]-THE SAME DAY TO PROVIDE REPAIR SERVICES. VENDOR CAME ON-SITE AND REPORTEDLY CLEANED AND TESTED THE INJECTOR, AND REMOVING LEFTOVER CONTRACT FROM THE PLUNGER AND DEVICE; THE THICK, VISCOUS FLUIDS HAD CAUSED THE MOVEMENTS TO SEIZE. ON [REDACTED]-THE DAY OF THE EVENT, THE DEVICE WAS CLEARED FOR USE ON [REDACTED]-THE NEXT DAY. ON [REDACTED]-THE NEXT DAY, PHYSICIAN PREPARING FOR THE PROCEDURE IDENTIFIED AGAIN THAT THE INJECTOR WAS NOT WORKING. THEY TROUBLESHOT AGAIN AND RECEIVED ERROR CODE 3016, AND STOPPED THE CASE WHEN THE CODE GENERATED, AS THEY WERE UNABLE TO COMMUNICATE APPROPRIATELY ACROSS THE INTEGRATED DEVICES. BAYER/MEDRAD WAS ENGAGED TO COME ON-SITE AGAIN FOR REPAIR. THEY REASSESSED, RECLEANED, REPLACED A PRINTED CIRCUIT BOARD, AND UPDATED THE SOFTWARE OF THE INJECTOR. AFTER THESE SERVICES, THE INJECTOR WAS AGAIN CLEARED FOR USE. [REDACTED]-8 DAYS AFTER FIRST DAY OF THE PROBLEM, PROCEDURE WAS SUCCESSFULLY PERFORMED. VENDOR WAS ON-SITE AND PERFORMED RE-EDUCATION TO STAFF ON CLEANING PROCESSES AT THIS TIME TO HOPEFULLY REDUCE THE INSTANCES OF VISCOUS CONTRAST ON THE DEVICE IN THE FUTURE.