MEDRAD® CENTARGO CT INJECTOR SYSTEM

Additional Manufacturer Narrative

ON (B)(6) 2026, A BAYER SERVICE REPRESENTATIVE VISITED THE CUSTOMER SITE, COLLECTED SYSTEM LOG FILES, REPLACED THE PATIENT LINE SENSOR (SUDS SENSOR), AND RESTORED THE SYSTEM TO NORMAL OPERATION. THE DISPOSABLE DAY SET AND PATIENT LINE INVOLVED IN THE INCIDENT WERE DISCARDED AND WERE THEREFORE UNAVAILABLE FOR EVALUATION. ALTHOUGH LOT NUMBERS WERE PROVIDED, RETAINED SAMPLES WERE NOT REQUESTED BECAUSE THE ISSUE WAS CONSIDERED RELATED TO THE INJECTION SYSTEM AND NOT THE DISPOSABLE PRODUCTS. BAYER PRODUCT ANALYSIS RECEIVED AND ANALYZED THE RETURNED SUDS SENSOR. VISUAL INSPECTION IDENTIFIED PHYSICAL DAMAGE AT THE SENSOR CORNER. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. LOG FILE REVIEW IDENTIFIED A SCENARIO IN WHICH THE SUDS SENSOR MAY HAVE NOT PERFORMED AS INTENDED, RESULTING IN FAILURE TO DETECT A PATIENT LINE CHANGE AND PREVENTING AUTOMATIC PRIMING. LOGS FURTHER CONFIRMED THAT NO MANUAL PRIMING WAS PERFORMED. AS A RESULT, AN UNPRIMED PATIENT LINE MAY HAVE BEEN CONNECTED TO THE PATIENT, ALLOWING AIR TO BE INTRODUCED DURING THE PROCEDURE. THE MEDRAD® CENTARGO CT INJECTION SYSTEM OPERATION MANUAL AND INSTRUCTIONS FOR USE FOR PATIENT LINE REQUIRE VERIFICATION THAT AIR IS REMOVED FROM THE PATIENT LINE AND CONFIRMATION OF THE "CHECK FOR AIR" PROMPT PRIOR TO INJECTION. BASED ON AVAILABLE INFORMATION, THESE STEPS MAY HAVE NOT BEEN ADEQUATELY PERFORMED. IN THIS INCIDENT, TO ARM THE INJECTOR, THE TECHNOLOGIST WOULD HAVE NEEDED TO CONFIRM THE CHECK FOR AIR POPUP BEFORE THE INJECTION BUT MAY HAVE NEGLECTED TO CHECK FOR AIR IN THE PATIENT LINE. THE BEST CLINICAL PRACTICE IS TO ENSURE THAT THE TUBING IS PRIMED/RE-PRIMED WITH FLUID, TO REMOVE AIR PRIOR TO ATTACHING TO THE PATIENT'S IV CATHETER AND VISUALLY CONFIRMED TO BE FREE OF AIR. IN THIS CASE, THE LOG FILES CONFIRMED THAT THE TECHNOLOGIST DID NOT PERFORM A MANUAL PRIME IN ORDER TO ENSURE A WET-TO-WET CONNECTION WHICH RESULTED IN THIS INCIDENT.

Description of Event or Problem

BAYER MEDICAL CARE WAS INFORMED OF AN EVENT WHERE AN UNDISCLOSED AMOUNT OF AIR WAS ALLEGEDLY INJECTED INTO A PATIENT DURING A CT SCAN WHILE CONNECTED TO THE MEDRAD® CENTARGO CT INJECTION SYSTEM (SERIAL NUMBER (B)(6). THE AIR WAS VISUALIZED IN THE IMAGING, BUT NO ADVERSE PATIENT EFFECTS WERE REPORTED.