CENTRYSYSTEM 3 PLUS

Description of Event or Problem

CUSTOMER REPORTED THEY HAD FIVE PYROGEN REACTIONS ASSOCIATED WITH THREE CENTRYSYSTEM 3 PLUS MACHINES OVER A FOUR WEEK PERIOD. ONE HOUR INTO A HEMODIALYSIS TREATMENT, THE PT COMPLAINED OF CHILLING. BLOOD CULTURES AND A CHEMISTRY 12 WERE DRAWN FROM THE PT. THE PT COMPLETED THE TREATMENT AND WAS THEN TRANSFERRED TO THE EMERGENCY ROOM, AND ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF SEPTICEMIA. THE PT WAS HOSPITALIZED FOR NINE DAYS AND THEN DISCHARGED HOME.

Additional Manufacturer Narrative

INSPECTION OF THIS MACHINE REVEALED A LEAK AT PB (BICART TEST) PORT. A LEAK AT THE PB PORT COULD INTRODUCE AIR INTO THE DISINFECTANT ASPIRATION CIRCUIT REDUCING THE AMOUNT OF DISINFECTANT UPTAKE AND DILUTION LEVEL IN THE MACHINE FLUID PATHWAY. THE DPA STROKE VOLUME WAS OUT OF SPECIFICATION BY 7 CC WHICH TRANSLATES INTO AN INADEQUATE AMOUNT OF (BLEACH) SOLUTION BEING DRAWN INTO THE MACHINE DURING CLEANING AND DISINFECTION. LOWER LEVELS OF BLEACH CONCENTRATE COULD RESULT IN INADEQUATE CLEANING OF THE BALANCE CHAMBER DIAPHRAGMS. THE ROOT CAUSE ANALYSIS FOR THE REPORTED CONDITION IS RELATED TO INADEQUATE OR NOT PROPERLY OR ROUTINELY CLEANING AND DISINFECTING THE MACHINE ACCORDING TO THE COBE CENTRYSYSTEM 3 PLUS OPERATOR'S MANUAL. THE CHEMICAL DWELL TIME WAS DECREASED FROM 120 MINUTES TO 15 MINUTES WHICH IS INADEQUATE TO CONTROL MICROORGANISM LEVELS TO BE WITHIN THE AAMI GUIDELINES. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT.