CENTRYSYSTEM 3 PLUS

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 REVEALED 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 LARVAE 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. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT.

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, CBC AND A CHEMISTRY 12 WERE DRAWN FROM THE PT. THE PT COMPLETED THE TREATMENT AND WAS TRANSFERRED TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF SEPTICEMIA. FOURTEEN DAYS LATER, THE PT WAS DISCHARGED HOME.