STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTOR (SERIAL NUMBER (B)(6)) WAS COMPLETED ON (B)(6) 2026, AND CONFIRMED THE DEVICE WAS OPERATING WITHIN BAYER PERFORMANCE SPECIFICATIONS. THE DISPOSABLE SET USED DURING THE REPORTED EVENT HAD BEEN DISCARDED BY THE FACILITY AND WAS UNAVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES IN USE AT THE TIME OF THE INCIDENT; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE CUSTOMER DECLINED AN OFFER FOR ADDITIONAL APPLICATIONS TRAINING. THE MEDRAD® STELLANT CT INJECTOR SYSTEM REMAINS IN CLINICAL USE AT THE CUSTOMER SITE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INJECTOR SYSTEM WAS MANUFACTURED IN ACCORDANCE WITH ESTABLISHED SPECIFICATIONS, WITH NO IDENTIFIED DEVIATIONS, NONCONFORMANCES, FAILURES, OR QUALITY RELATED ISSUES. 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

BAYER MEDICAL CARE BECAME AWARE OF AN ALLEGED AIR INJECTION THAT OCCURRED DURING A CT EXAMINATION OF THE CHEST WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE ADMINISTRATION OF 20 ML OF SALINE AT A PROGRAMMED FLOW RATE OF 3 ML/SECOND, INTRAVASCULAR AIR WAS IDENTIFIED ON THE ACQUIRED CT IMAGES IN THE LEFT INNOMINATE VEIN. A SUBSEQUENT NON-CONTRAST SCAN WAS PRESCRIBED AND DEMONSTRATED REABSORPTION OF THE AIR. THE PATIENT WAS MONITORED ON SITE AND REMAINED CLINICALLY STABLE, WITH NO REPORTED SYMPTOMS.