ANGIOMAT ILLUMENA

Description of Event or Problem

DURING THE COURSE OF RESPONDING TO A REQUEST FOR SERVICE, THE LIEBEL-FLARSHEIM FSE WAS ADVISED BY THE CUSTOMER OF A POSSIBLE AIR INJECTION. ELEVEN DAYS LATER: CUSTOMER REPORTS THE FOLLOWING, "A MALE HAVING A CARDIAC CATH TO R/O CAD. DURING THE PROCEDURE, THE PHYSICIAN PERFORMED AN INJECTION OF THE LEFT CORONARY ARTERY WITH THE ILLUMENA POWER INJECTOR, AND ALLEGEDLY AIR WAS INJECTED INSTEAD OF CONTRAST MEDIA. THE INJECTION PROTOCOL WAS SET FOR 4ML/SEC FOR A VOLUME OF 7ML WITH AN OPTIRAY 350 PREFILLED SYRINGE LOADED IN THE INJECTOR. CATHETER AND TUBING ATTACHED TO THE INJECTOR IS UNK. THE LOT NUMBER AND EXPIRATION DATE OF THE OPTIRAY CONTRAST MEDIA IS UNK AND ALL PRODUCT HAS BEEN DISCARDED. CUSTOMER STATES THAT THEY FEEL THERE WAS NO ERROR OR MALFUNCTION OF THE ILLUMENA POWER INJECTOR. PT WAS DISCHARGED HOME IN GOOD CONDITION AND IS DOING FINE.

Additional Manufacturer Narrative

LIEBEL FLARSHEIM FIELD SERVICE REPORT: FIELD SERVICE ENGINEER CHECKED AND VERIFIED 'USED SYRINGE MESSAGE', 'FILL SEQUENCE' MESSAGES, AND 'CHECK FOR AIR' MESSAGE. PERFORMED OPERATIONAL CHECK OUT PROCEDURES ACCORDING TO SERVICE MANUAL. PERFORMED INJECTIONS AND VERIFIED INJECTOR OPERATION. INJECTION WORKING ACCORDING TO MFR SPECIFICATIONS AS PER ILLUMENA SERVICE MANUAL. INJECTOR SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.