MEDRAD® CENTARGO CT INJECTOR

Description of Event or Problem

BAYER MEDICAL CARE WAS NOTIFIED OF A CONTRAST ADMINISTRATION INCIDENT THAT OCCURRED ON (B)(6) 2026, DURING A CT RUNOFF EXAMINATION AT THE CUSTOMER'S SITE WHILE THE MEDRAD® CENTARGO CT INJECTOR SYSTEM WAS IN USE. DESPITE THE PATIENT'S INITIAL INTRAVENOUS ACCESS BEING NOTED BY THE TECHNOLOGIST AS SUBOPTIMAL, THE INJECTION WAS STILL INITIATED. EARLY IN THE CONTRAST PHASE, THE IV BECAME INTERSTITIAL, RESULTING IN APPROXIMATELY (B)(6) OF CONTRAST EXTRAVASATING INTO THE SURROUNDING TISSUE. ACQUIRED CT IMAGES DEMONSTRATED NO INTRAVASCULAR ENHANCEMENT, AND THE INJECTION WAS HALTED DURING THE POST-CONTRAST SALINE PHASE. A NEW INTRAVENOUS CATHETER WAS ESTABLISHED, AND THE TECHNOLOGIST ATTEMPTED TO REIMAGE THE PATIENT. ACCORDING TO THE CUSTOMER'S EMAIL, WHEN THE INJECTOR WAS ACTIVATED, AN ADDITIONAL BOLUS OF CONTRAST WAS DELIVERED. A SECOND TECHNOLOGIST IDENTIFIED THAT A TEST SALINE INJECTION WAS NOT PERFORMED FIRST, AND THE CONTRAST INJECTION WAS STOPPED AFTER APPROXIMATELY (B)(6) HAD BEEN ADMINISTERED. A FULL REPEAT INJECTION OF (B)(6) WAS LATER PERFORMED TO OBTAIN DIAGNOSTIC IMAGES. IN TOTAL, THE PATIENT RECEIVED APPROXIMATELY (B)(6) OF CONTRAST ACROSS THE THREE INJECTION ATTEMPTS. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH CONTRAST-RELATED ACUTE KIDNEY INJURY ATTRIBUTED TO THE TOTAL CONTRAST VOLUME ADMINISTERED. DESPITE ADDITIONAL ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE PATIENT'S STATUS AND THE RESULTS OF THE CUSTOMER'S INTERNAL INVESTIGATION, NO RESPONSE HAS BEEN RECEIVED.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTOR (SN (B)(6)) WAS COMPLETED ON MARCH 5, 2026, BY A BAYER SERVICE REPRESENTATIVE, WHO CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. BAYER CLINICAL SUPPORT PROVIDED FOLLOW UP TRAINING ON MARCH 4, 2026, AT THE CUSTOMER'S REQUEST. REVIEW OF THE INJECTOR LOG FILES SHOWED THAT CONTRAST DELIVERY OCCURRED DURING INJECTIONS INITIATED BY THE USER AND IN ACCORDANCE WITH THE WORKFLOW SETTINGS SELECTED BY THE USER. THE RECORDED ACTIVITY INCLUDED ONE TEST INJECTION AND THREE CONTRAST DOSE INJECTIONS. TWO OF THE CONTRAST INJECTIONS WERE MANUALLY STOPPED BY THE USER PRIOR TO COMPLETION. THE TOTAL VOLUME OF CONTRAST DELIVERED WAS APPROXIMATELY (B)(6). 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 A CONTRAST ADMINISTRATION INCIDENT THAT OCCURRED ON (B)(6) 2026, DURING A CT RUNOFF EXAMINATION AT THE CUSTOMER'S SITE WHILE THE MEDRAD® CENTARGO CT INJECTOR SYSTEM WAS IN USE. DESPITE THE PATIENT'S INITIAL INTRAVENOUS ACCESS BEING NOTED BY THE TECHNOLOGIST AS SUBOPTIMAL, THE INJECTION WAS STILL INITIATED. EARLY IN THE CONTRAST PHASE, THE IV BECAME INTERSTITIAL, RESULTING IN APPROXIMATELY 111 ML OF CONTRAST EXTRAVASATING INTO THE SURROUNDING TISSUE. ACQUIRED CT IMAGES DEMONSTRATED NO INTRAVASCULAR ENHANCEMENT, AND THE INJECTION WAS HALTED DURING THE POST-CONTRAST SALINE PHASE. A NEW INTRAVENOUS CATHETER WAS ESTABLISHED, AND THE TECHNOLOGIST ATTEMPTED TO REIMAGE THE PATIENT. ACCORDING TO THE CUSTOMER'S EMAIL, WHEN THE INJECTOR WAS ACTIVATED, AN ADDITIONAL BOLUS OF CONTRAST WAS DELIVERED. A SECOND TECHNOLOGIST IDENTIFIED THAT A TEST SALINE INJECTION WAS NOT PERFORMED FIRST, AND THE CONTRAST INJECTION WAS STOPPED AFTER APPROXIMATELY 66 ML HAD BEEN ADMINISTERED. A FULL REPEAT INJECTION OF 111 ML WAS LATER PERFORMED TO OBTAIN DIAGNOSTIC IMAGES. IN TOTAL, THE PATIENT RECEIVED APPROXIMATELY 288 ML OF CONTRAST ACROSS THE THREE INJECTION ATTEMPTS. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH CONTRAST-RELATED ACUTE KIDNEY INJURY ATTRIBUTED TO THE TOTAL CONTRAST VOLUME ADMINISTERED. THE STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. AN INTERNAL INVESTIGATION IS BEING CONDUCTED AT THE CUSTOMER SITE.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® CENTARGO CT INJECTOR (SN (B)(6)) WAS COMPLETED ON MARCH 5, 2026, BY A BAYER SERVICE REPRESENTATIVE, WHO CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN SPECIFICATIONS. BAYER SERVICE IS CURRENTLY EVALUATING LOG FILES FROM THE INJECTOR SYSTEM FROM THE TIME OF ALLEGATION. BAYER CLINICAL SUPPORT PROVIDED FOLLOW UP TRAINING ON MARCH 4, 2026, AT THE CUSTOMER'S REQUEST. 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.