ELITE, BASE MODE

Additional Manufacturer Narrative

OVERALL INVESTIGATION SUMMARY A COMPLAINT WAS RECEIVED ON OPTISTAR ELITE INJECTOR 814001C SERIAL NUMBER (B)(6) ALLEGING THAT THERE WAS A FAILURE WHILE INJECTING A CONTRAST AGENT INTO A PATIENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE CUSTOMER REPORTED THAT DURING THE PATIENT'S MAGNETIC RESONANCE IMAGING (MRI) EXAMINATION AND WHILE INJECTING CONTRAST AGENT TO THE PATIENT, THE HIGHPRESSURE INJECTOR REPORTED AN ERROR *ALARM 15 AND FAILED TO COMPLETE THE INJECTION. THERE WAS NO REPORTED PATIENT INJURY, BUT THE DEVICE FAILURE LED TO A DELAY TO ABOUT A DAY. A DIFFERENT INJECTOR WAS UTILIZED TO COMPLETE THE PROCEDURE AFTER THE DELAY. SERVICE NOTED THAT THE ALARM 15 WAS NOT PROMPTED WHEN TURNING ON THE UNIT BUT WAS INTERMITTENT WHEN IN USE OR STANDBY MODE. THIS COULD NOT CONSISTENTLY BE REPLICATED TO FIND A ROOT CAUSE. FOLLOWING A STANDARD PROGRESSIVE APPROACH, THE SERVICE ENGINEER WOULD START WITH THE MOST PROBABLE CAUSE PER THE SERVICE MANUAL. THIS DID NOT SEEM TO CORRECT THE INTERMITTENT ISSUE. THE SERVICE ENGINEER REPLACED THE POWER CONTROL MAIN PCB, WHICH CORRECTED THE ISSUE TEMPORARILY. THE ENGINEER WAS CALLED BACK OUT WHEN THE ISSUE RECURRED SEVERAL TIMES AND THE OTHER POWER CONTROL BOARDS WERE REPLACED. SINCE THESE REPLACEMENTS, THE INJECTOR HAS BEEN FUNCTIONING WITHOUT ISSUE. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO PREVIOUSLY REPORTED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B01; C02, C0201; D02 ROOT / PROBABLE CAUSE CODE DEFECTIVE CIRCUIT BOARD ROOT / PROBABLE CAUSE SUMMARY REFER TO INVESTIGATION SUMMARY. NO ADDITIONAL CAPA REQUIRED AT THIS TIME. GUERBET QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEWS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY UNIT RETURNED TO SERVICE.

Description of Event or Problem

THIS CASE WAS REPORTED BY A FACILITY IN (B)(6), CHINA ON 05 SEPTEMBER 2025. CUSTOMER REPORTS THAT ON (B)(6) 2025, DURING THE PATIENT'S MAGNETIC RESONANCE IMAGING (MRI) EXAMINATION AND WHILE INJECTING CONTRAST AGENT TO THE PATIENT, THE HIGH-PRESSURE INJECTOR REPORTED AN ERROR AND FAILED TO COMPLETE THE INJECTION. PATIENT WAS CONNECTED. PROCEDURE WAS COMPLETED WITH DAY DELAY, UNKNOWN CONTRAST, NO CLINICAL CONSEQUENCES. .