AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WERE INDICATIONS OF BURNT OR CHARRED WIRING IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE CUSTOMER INITIALLY CONTACTED FRESENIUS FOR ASSISTANCE AFTER THE RO SYSTEM RECEIVED A T1 TEST, PUMP P1S DEFECTIVE ERROR DURING THE T1 TEST. ERROR CODE F-04-51-04 WAS RECEIVED. DURING TROUBLESHOOTING THE MOTOR PROTECTION SWITCH IN STAGE 2 WAS FOUND TO BE TRIPPED. THE SWITCH WAS RESET. THE VOLTAGE AT THE POWER SWITCH WAS TESTED FOR STAGE 2 AND WAS FOUND TO BE MISSING A LEG. THE FUSES IN THE MAIN POWER BOX WERE ALSO TESTED AND A BAD FUSE WAS FOUND. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. IT WAS CONFIRMED THAT THE POWER SWITCH AND LEG ONE CONNECTOR SUSTAINED THERMAL DAMAGE. A BURNING SMELL OBSERVED. IT WAS NOT INDICATED BY THE BIOMED THAT SMOKE, SPARK, FLAME, OR ARCING WERE OBSERVED. THE BIOMED SUSPECTED THE CAUSE OF THE FAILURE TO BE TOO MANY AMPS PULLING POWER ON LEG ONE OR THE CIRCUIT BEING UNDERSIZED FOR WHAT IT CONTROLS. THE THERMAL OVERLOAD RELAY DID NOT TRIP IN EITHER STAGE. A BLOWN FUSE WAS IDENTIFIED IN LEG ONE (WHERE 25-AMP FUSES ARE USED). THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE NOR WERE THERE ANY STORMS IN THE AREA AROUND THE TIME OF THE REPORTED ISSUE. THE RO SYSTEM IS PLUGGED INTO ITS OWN CIRCUIT BREAKER. THE POWER SWITCH, LEG ONE WIRE AND CONNECTOR, AND LEG ONE FUSE WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN SD CARD WAS NOT INSTALLED WHICH PREVENTS MACHINE FILES FROM BEING OBTAINED FOR REVIEW BY THE MANUFACTURER.

Additional Manufacturer Narrative

CORRECTION: H10 (PLANT INVESTIGATION) PLANT INVESTIGATION: ACCORDING TO THE PROVIDED INFORMATION, THE POWER SWITCH, LEG ONE WIRE AND CONNECTOR, AND LEG ONE FUSE WERE REPLACED TO RESOLVE THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED ISSUE USING THE INFORMATION PROVIDED BY THE CUSTOMER. THE THERMAL DAMAGE WAS CAUSED BY LOW CONTACT PRESSURE WHICH RESULTED IN CONTACT RESISTANCE AT THE BAD CONTACTED POINT AND A HIGH THERMAL POWER LOSS WAS INDICATED, NOTED AS THE THERMAL DAMAGE. THIS FAILURE PATTERN IS KNOWN AND COVERED BY AN INTERNAL CAPA PROJECT. CORRECTIVE ACTIONS OF THE CAPA WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED. THE AFFECTED DEVICE WAS BUILT BEFORE THE IMPLEMENTATION OF THE CAPA AND WAS STILL EQUIPPED WITH THE OLD DESIGN OF THE CRIMPED CABLE LUG AT TIME OF THE FAILURE ACCORDING TO THE PROVIDED PICTURE. ACCORDING TO THE PROVIDED INFORMATION NO PARTS WERE REPLACED. IT IS THEREFORE RECOMMENDED TO CHECK IF REPLACED WIRING MATCHES THE SPECIFICATIONS OF THE CORRECTIVE ACTIONS AND REPLACE ANY PARTS NECESSARY TO CORRESPOND TO IT.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WERE INDICATIONS OF BURNT OR CHARRED WIRING IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE CUSTOMER INITIALLY CONTACTED FRESENIUS FOR ASSISTANCE AFTER THE RO SYSTEM RECEIVED A T1 TEST, PUMP P1S DEFECTIVE ERROR DURING THE T1 TEST. ERROR CODE F-04-51-04 WAS RECEIVED. DURING TROUBLESHOOTING THE MOTOR PROTECTION SWITCH IN STAGE 2 WAS FOUND TO BE TRIPPED. THE SWITCH WAS RESET. THE VOLTAGE AT THE POWER SWITCH WAS TESTED FOR STAGE 2 AND WAS FOUND TO BE MISSING A LEG. THE FUSES IN THE MAIN POWER BOX WERE ALSO TESTED AND A BAD FUSE WAS FOUND. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. IT WAS CONFIRMED THAT THE POWER SWITCH AND LEG ONE CONNECTOR SUSTAINED THERMAL DAMAGE. A BURNING SMELL OBSERVED. IT WAS NOT INDICATED BY THE BIOMED THAT SMOKE, SPARK, FLAME, OR ARCING WERE OBSERVED. THE BIOMED SUSPECTED THE CAUSE OF THE FAILURE TO BE TOO MANY AMPS PULLING POWER ON LEG ONE OR THE CIRCUIT BEING UNDERSIZED FOR WHAT IT CONTROLS. THE THERMAL OVERLOAD RELAY DID NOT TRIP IN EITHER STAGE. A BLOWN FUSE WAS IDENTIFIED IN LEG ONE (WHERE 25-AMP FUSES ARE USED). THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE NOR WERE THERE ANY STORMS IN THE AREA AROUND THE TIME OF THE REPORTED ISSUE. THE RO SYSTEM IS PLUGGED INTO ITS OWN CIRCUIT BREAKER. THE POWER SWITCH, LEG ONE WIRE AND CONNECTOR, AND LEG ONE FUSE WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN SD CARD WAS NOT INSTALLED WHICH PREVENTS MACHINE FILES FROM BEING OBTAINED FOR REVIEW BY THE MANUFACTURER.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERE WERE INDICATIONS OF BURNT OR CHARRED WIRING IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE CUSTOMER INITIALLY CONTACTED FRESENIUS FOR ASSISTANCE AFTER THE RO SYSTEM RECEIVED A T1 TEST, PUMP P1S DEFECTIVE ERROR DURING THE T1 TEST. ERROR CODE F-04-51-04 WAS RECEIVED. DURING TROUBLESHOOTING THE MOTOR PROTECTION SWITCH IN STAGE 2 WAS FOUND TO BE TRIPPED. THE SWITCH WAS RESET. THE VOLTAGE AT THE POWER SWITCH WAS TESTED FOR STAGE 2 AND WAS FOUND TO BE MISSING A LEG. THE FUSES IN THE MAIN POWER BOX WERE ALSO TESTED AND A BAD FUSE WAS FOUND. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. IT WAS CONFIRMED THAT THE POWER SWITCH AND LEG ONE CONNECTOR SUSTAINED THERMAL DAMAGE. A BURNING SMELL OBSERVED. IT WAS NOT INDICATED BY THE BIOMED THAT SMOKE, SPARK, FLAME, OR ARCING WERE OBSERVED. THE BIOMED SUSPECTED THE CAUSE OF THE FAILURE TO BE TOO MANY AMPS PULLING POWER ON LEG ONE OR THE CIRCUIT BEING UNDERSIZED FOR WHAT IT CONTROLS. THE THERMAL OVERLOAD RELAY DID NOT TRIP IN EITHER STAGE. A BLOWN FUSE WAS IDENTIFIED IN LEG ONE (WHERE 25-AMP FUSES ARE USED). THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE NOR WERE THERE ANY STORMS IN THE AREA AROUND THE TIME OF THE REPORTED ISSUE. THE RO SYSTEM IS PLUGGED INTO ITS OWN CIRCUIT BREAKER. THE POWER SWITCH, LEG ONE WIRE AND CONNECTOR, AND LEG ONE FUSE WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN SD CARD WAS NOT INSTALLED WHICH PREVENTS MACHINE FILES FROM BEING OBTAINED FOR REVIEW BY THE MANUFACTURER.