MRXPERION MR INJECTION SYSTEM

Description of Event or Problem

A BAYER SERVICE REPRESENTATIVE WAS ONSITE TO INSTALL A NEW MEDRAD® MRXPERION INJECTION SYSTEM IN A NEW MRI SUITE. A SCREWDRIVER THAT THE REPRESENTATIVE WAS USING WAS PULLED INTO THE CANON MAGNET BORE. THE TOOL WAS ABLE TO BE REMOVED WITHOUT HAVING TO RAMP DOWN THE MAGNET. NO INJURY OR ADVERSE EVENT WAS REPORTED.

Additional Manufacturer Narrative

A BAYER FIELD SERVICE REPRESENTATIVE WAS ONSITE AT THE HOSPITAL TO INSTALL A NEW MEDRAD® MRXPERION INJECTION SYSTEM. DURING INSTALLATION, A FERROUS SCREWDRIVER WAS INADVERTENTLY BROUGHT INTO THE SCAN ROOM AND WAS SUBSEQUENTLY DRAWN INTO THE MAGNET BORE. THIS, IN TURN, CAUSED SOME COSMETIC DAMAGE TO THE SCANNER COVER WHICH BAYER IS PAYING TO REPLACE FOR THE CUSTOMER. THE SCREWDRIVER WAS ABLE TO BE REMOVED FROM THE MAGNET WITHOUT HAVING TO RAMP DOWN/QUENCH THE MAGNET. BAYER PRODUCT ANALYSIS INTERVIEWED THE FIELD SERVICE MANAGER AND CONFIRMED THAT ALL BAYER FIELD SERVICE REPRESENTATIVES WHO WORK IN AN MR ENVIRONMENT RECEIVE MR TRAINING ANNUALLY. THIS MRI SAFETY TRAINING CLEARLY STATES THAT FERROUS TOOLS ARE NOT TO BE USED IN AN MRI SUITE. BAYER FURTHER CONFIRMED THAT THE REPRESENTATIVE WHO WAS PERFORMING THIS INSTALLATION HAD COMPLETED THE REQUIRED TRAINING AND REMAINS UP-TO DATE. THEREFORE, OUR INVESTIGATION CONCLUDED THAT THE INCIDENT OCCURRED DUE TO USER ERROR DURING INJECTOR INSTALLATION BY THE BAYER EMPLOYEE WHICH WILL BE ADDRESSED DIRECTLY WITH THIS EMPLOYEE. ADDITIONALLY, FURTHER EVALUATION WILL TAKE PLACE VIA BAYER'S CAPA (CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) PROCESS.

Additional Manufacturer Narrative

THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A BAYER SERVICE REPRESENTATIVE WAS ON SITE TO INSTALL A NEW MEDRAD® MRXPERION INJECTION SYSTEM IN A NEW MRI SUITE. A SCREWDRIVER THAT THE REPRESENTATIVE WAS USING WAS PULLED INTO THE CANON MAGNET BORE. THE TOOL WAS ABLE TO BE REMOVED WITHOUT HAVING TO RAMP DOWN THE MAGNET. NO INJURY OR ADVERSE EVENT WAS REPORTED.