MEDRAD® STELLANT CT INJECTION SYSTEM WITH CENTEGRA WORKSTATION
Received May 7, 2026 · Event occurred Apr 25, 2026
Report 2520313-2026-00015 · MDR key 25111006
Device
Generic name
Ct Injection System
Manufacturer
Bayer Medical Care Inc.Model number
85937286Catalog number
SCT W/CERTEGRA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
64 YR · Female
- Air Embolism
Narrative
Additional Manufacturer Narrative
THIS INVESTIGATION REMAINS IN PROGRESS. 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.
Description of Event or Problem
BAYER MEDICAL CARE INC. WAS INFORMED OF AN ALLEGED AIR INJECTION INVOLVING A FEMALE PATIENT THAT OCCURRED ON (B)(6) 2026, DURING A CT EXAMINATION OF THE HEAD AND CHEST WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). ACCORDING TO THE INFORMATION PROVIDED, AIR BUBBLES WERE OBSERVED ON IMAGING WITHIN THE JUGULAR VEIN, ENCEPHALIC VEIN, AND SUPERIOR VENA CAVA. AS A PRECAUTIONARY MEASURE, THE PATIENT'S LEGS WERE ELEVATED AND THE OXYGEN CONCENTRATION WAS INCREASED FROM 25% TO 50%, AS DIRECTED BY THE ANESTHETIST. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED.