STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE STELLANT FLEX CT INJECTOR, SERIAL NUMBER (B)(6), WAS COMPLETED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE MEDRAD® STELLANT FLEX DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE CUSTOMER; 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. THE CUSTOMER DECLINED THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. THE MEDRAD® STELLANT FLEX 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

BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE PATIENT WAS PLACED IN LEFT LATERAL DECUBITUS POSITION, ADMINISTERED SUPPLEMENTAL OXYGEN AT 15L, AND ADMITTED TO THE INTENSIVE CARE UNIT FOR TELEMETRY AND MONITORING. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.