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Patient 1
THE INVESTIGATION AND THE ANALYSIS OF THE ROOT CAUSE HAVE BEEN COMPLETED BY PRODUCT DISTRIBUTOR FSE. THE FSE FOUND THAT THE CAUSE OF THE SIRIUS BOARD BURNING WAS DUE TO A WRONG CONNECTION OF THE CABLE WITH PART NUMBER 475283020 CONDUCTING 24V. THE ISSUE WAS A SINGLE EVENT LIKELY DUE TO A MANUFACTURING PROBLEM. NO OTHER OCCURRENCE WAS REPORTED FROM THE FIELD. SINCE THE EVENT OCCURRED DURING THE AUTOMATION SYSTEM INSTALLATION PHASE, THERE WERE NO PATIENT SAMPLES INVOLVED. THE FSE, WHO IS A TRAINED PERSON ON THE USE OF THE SYSTEM, WAS ON SITE AND WAS WORKING ON THE IMPACTED MODULE. ALL THE ELECTRICAL COMPONENTS INCLUDED IN THE AUTOMATION SYSTEM, ARE TESTED FOR FLAME RETARDANCY AND THEY HAVE A FLAMMABILITY RATING AT LEAST V-2: IN CASE OF FIRE THE ELECTRIC PARTS ARE AUTO EXTINGUISHING IN 10-30 SECONDS WITHOUT ANY INTERVENTION OF SERVICE AND LABORATORY PERSONNEL. THE FSE REPLACED THE ATR SIRIUS BOARD USING THE CORRECT CABLE CONNECTION. THERE WAS NO INJURY ASSOCIATED TO THE EVENT NEITHER FOR THE LABORATORY PERSONNEL NOR FOR THE FSE. AFTER THE REPLACEMENT AND THE REPROGRAMMING OF THE ELECTRICAL BOARD, THE ATR IS WORKING AS EXPECTED AND NO SIMILAR EVENT HAS BEEN REPORTED FROM THE FIELD. AS IMMEDIATE ACTION, THE FSE REPLACED THE DAMAGED COMPONENTS. NO PREVENTIVE ACTION IS REQUIRED ACCORDING TO INVESTIGATION FINDINGS. THERE IS NO NEED TO CONDUCT A FIELD SAFETY CORRECTIVE ACTION SINCE THE EVENT WAS A SINGLE OCCURRENCE AND, AS CONFIRMED BY THE PRODUCT DISTRIBUTOR ALSO, THE EVENT WAS NOT DUE TO A DESIGN ISSUE, SO IT HAS BEEN EVALUATED NOT NECESSARY TO IMPLEMENT A DESIGN CHANGE.