STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM, (B)(6), WAS COMPLETED ON MAY 13, 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE LOT NUMBER FOR THE DISPOSABLES IN USE AT THE TIME OF THE INCIDENT WAS NOT PROVIDED; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN MADE TO THE CUSTOMER, AND WE ARE AWAITING THEIR RESPONSE. THE SITE CONTINUES TO USE THE STELLANT CT INJECTION SYSTEM AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE 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 WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (B)(6). DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT APPROXIMATELY 93ML OF AIR WAS INJECTED AND THE PATIENT WAS REPORTED TO HAVE EXHIBITED COUGHING AND SHORTNESS OF BREATH. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER EVALUATION AND WAS DISCHARGED TO HOME THE FOLLOWING DAY WITH NO FURTHER ISSUES REPORTED.