STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

THE OFFER OF AN INJECTOR CHECK BY BAYER SERVICE HAS BEEN DECLINED BY THE CUSTOMER. THE MEDRAD® STELLANT DISPOSABLE SET THAT WAS IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED; HOWEVER, THE CUSTOMER DECLINED. THE SITE CONTINUES TO USE THE STELLANT CT INJECTION SYSTEM AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THE FOLLOWING: A PATIENT WAS UNDERGOING AN ENHANCED CT SCAN WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE SUBSEQUENT IMAGES. THE PATIENT WAS PLACED ON HIGH FLOW OXYGEN VIA A NON-REBREATHER FACEMASK AND WAS PLACED ON THEIR LEFT SIDE IN TRENDELENBURG POSITION. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED THE FOLLOWING DAY WITHOUT FURTHER ISSUE.