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 PATIENT COMPLAINED OF CHILLING. BLOOD, CULTURES, CBC AND A CHEMISTRY 12 WERE DRAWN FROM THE PATIENT. THE PATIENT COMPLETED THE TREATMENT AND WAS THEN TRANSFERRED TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF SEPTICEMIA.

Additional Manufacturer Narrative

INSPECTION OF THIS MACHINE REVEALED THERE WAS A BLACK DISCOLORATION AND BUILD UP IN THE VACUUM LINE MID WAY BETWEEN THE HD CHAMBER AND VACUUM REGULATOR. VISUAL INSPECTION OF THE BALANCE CHAMBER DIAPHRAGM REVELED THERE WERE NO VISIBLE TEARS OF THE DIAPHRAGM. THERE WAS HOWEVER, SIGNIFICANT LEVELS OF SUSPECTED YEAST BUILD UP 1/8 INCH THICK ON THE WASTE SIDE OF THE DIAPHRAGM. INSECT EGG CASES WERE OBSERVED ALL OVER THE DIAPHRAGMS ALONG WITH LIVE INSECT LARVE FEEDING ON THE DEPOSITS. THE REPORTED CONDITION COULD OCCUR IF THE VACUUM REGULATOR IS NOT DISINFECTED DURING ACDR. THE DPA & DPB STROKE VOLUME WERE OUT OF SPECIFICATION BY 6 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 GUIDELINES.