MEDRAD® CENTARGO CT INJECTOR SYSTEM

Description of Event or Problem

BAYER MEDICAL CARE RECEIVED A REPORT OF AN ALLEGED AIR INJECTION DURING USE OF A MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6). A 44-YEAR-OLD MALE PATIENT WAS UNDERGOING A CONTRAST ENHANCED ABDOMEN AND PELVIS CT EXAMINATION TO RULE OUT HEPATIC INJURY STATUS POST MOTOR VEHICLE CRASH (MVC). APPROXIMATELY LESS THAN 10ML OF AIR WAS REPORTEDLY VISUALIZED IN THE RIGHT VENTRICLE OF THE HEART ON THE DISPLAYED IMAGES. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL AND NO FURTHER INFORMATION REGARDING THEIR STATUS WAS PROVIDED.

Additional Manufacturer Narrative

THE MEDRAD® CENTARGO DAY SET AND PATIENT LINE DISPOSABLE SETS THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBERS OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED; HOWEVER, THE CUSTOMER DECLINED. A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SN (B)(6) HAS BEEN REQUESTED AND WE ARE AWAITING THE RESULTS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.