BASE SYSTEM, ILLUMENA

Additional Manufacturer Narrative

OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON ILLUMENA INJECTOR 900001C SERIAL NUMBER (B)(6) ALLEGING THE INJECTOR FAILED TO WORK NORMALLY. THE INJECTOR WAS RESTARTED MULTIPLE TIMES, AND DID NOT RETURN TO NORMAL FUNCTION, RESULTING IN DELAY IN THE PROGRESS OF THE OPERATION. THE FIELD SERVICE ENGINEER WENT ON SITE TO INVESTIGATE. THE SERVICE ENGINEER TROUBLESHOT THE SYSTEM PER THE SERVICE MANUAL, FINDING THAT THE SYSTEM PROMPTED ERRORS PP 0013, PP 0044, AND PP 0003 AT POWER UP, AND REPLACED THE POWER HEAD CONTROL PCB 903040-1 USING SERVICE KIT PN 903040S. THE UNIT WAS TESTED FOR PROPER OPERATION AND RELEASED FOR CUSTOMER USE. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED 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) ON (B)(6) 2025. CUSTOMER REPORTS THAT AT 22:15 ON (B)(6) 2025, THE PATIENT WAS ADMITTED WITH A CHIEF COMPLAINT OF "DIZZINESS FOR 1 DAY" AND DIAGNOSED WITH: 1. MULTIPLE BRAIN INFARCTIONS; 2. HYPERTENSION GRADE 3 (VERY HIGH RISK); 3. TYPE 2 DIABETES MELLITUS; 4. CORONARY ARTERY ATHEROSCLEROTIC HEART DISEASE WITH CARDIAC FUNCTION CLASS . CRANIAL MAGNETIC RESONANCE ANGIOGRAPHY (MRA) REVEALED: 1. AN ANEURYSM IN THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY, WITH A RECOMMENDATION FOR FURTHER EXAMINATION; 2. MULTIPLE SMALL LESIONS BRAIN INFARCTIONS AND PARTIAL ENCEPHALOMALACIA LESIONS. AT 08:30 ON (B)(6) 2025, THE PATIENT UNDERWENT "PERCUTANEOUS ARTERIAL CATHETERIZATION FOR TOTAL CEREBRAL ANGIOGRAPHY + INTRACRANIAL ANEURYSM EMBOLIZATION" IN THE CATHETERIZATION LABORATORY. DURING THE OPERATION, THE HIGH-PRESSURE INJECTOR FAILED TO WORK NORMALLY. EVEN AFTER MULTIPLE RESTARTS, THE DEVICE REMAINED NON-FUNCTIONAL. THE MEDICAL ENGINEERING DEPARTMENT WAS IMMEDIATELY NOTIFIED TO FEED BACK THE ISSUE TO THE MANUFACTURER, AND THIS MALFUNCTION AFFECTED THE PROGRESS OF THE PATIENT'S OPERATION.