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Patient 1
IN TRACKING COMPLAINTS OVER THE PAST 7 YEARS, IT WAS NOTICED THAT CERTAIN PREPMATE VIAL PROCESSORS EXHIBITED SMOKING, SPARKLING OR SMALL, SELF EXTINGUISHING FLAMES ON ONE SMALL CIRCUIT BOARD INTERNAL TO THE INSTRUMENT. THIS OCCURS MOST FREQUENTLY IN LARGE VOLUME LABS THAT PROCESS HIGH NUMBERS OF SAMPLES AND CLEAN THE INSTRUMENT MORE AGGRESSIVELY. THERE HAVE BEEN NO INJURIES, DEATHS OR DAMAGE ASSOCIATED WITH THESE OCCURRENCES. WHILE BD-TRIPATH HAS ATTEMPTED TO PREVENT THESE EVENTS BY REMINDING USERS OF THE CLEANING INSTRUCTIONS IN THE LABELING AND INSTALLING COATED BOARDS THAT SELF EXTINGUISH ANY FLAMES, THIS TREND HAS INCREASED IN THE LAST 30 DAYS (5 INSTANCES). THE PROBLEM STEMS FROM THE USER SPRAYING THE MACHINE WITH DISINFECTANT SOLUTION RATHER THAN WIPING IT WITH A CLOTH OR SPRAYED WITH THE DISINFECTANT. THE EXCESSIVE LIQUID OR SPRAY HAS COME IN CONTACT WITH THE CIRCUIT BOARD AND CAUSED CORROSION. OVER TIME THE BOARD BECOMES CORRODED ENOUGH TO MALFUNCTION RESULTING IN AN ELECTRICAL SHORT AND SPARKS, SMOKE OR SMALL FLAMES. USER CLEANING ERROR.