STELLANT DUAL CT INJECTOR

Description of Event or Problem

BAYER MEDICAL CARE WAS NOTIFIED OF AN EXTRAVASATION THAT OCCURRED DURING AN ENHANCED CT SCAN WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(6). DURING THE INJECTION, THE PATIENT COMPLAINED OF PAIN, SWELLING AND TIGHTNESS IN THEIR ARM. THE CUSTOMER REPORTED THAT APPROXIMATELY 30ML OF SALINE AND CONTRAST HAD EXTRAVASATED AT THE PATIENT'S LEFT ANTECUBITAL INJECTION SITE TO WHICH A COLD COMPRESS WAS APPLIED. IN ADDITION, THE ATTENDING PHYSICIAN PRESCRIBED THE APPLICATION OF MAGNESIUM SULPHATE AND DEXAMETHASONE TO THE INJECTION SITE. THE PATIENT IS REPORTED TO BE DOING WELL WITH NO OTHER ISSUES REPORTED.

Additional Manufacturer Narrative

THE OFFER OF A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), AS WELL AS ADDITIONAL CLINICAL APPLICATIONS TRAINING, WAS DECLINED BY THE CUSTOMER. COMMUNICATION FROM THE CUSTOMER WAS THAT THEIR FACILITY PERFORMS A LARGE NUMBER OF CHEMORADIOTHERAPY PROCEDURES AND THE RISK OF EXTRAVASATION FOR THOSE PATIENTS IS HIGH AS COMPARED TO TYPICAL PATIENTS. THE CUSTOMER ALSO PROVIDED THAT THE PHYSICIANS OF THE DEPARTMENT ARE VERY SKILLED WITH THE INJECTOR AND CONTINUE TO USE THE MEDRAD® 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. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.