AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS THAT CHARRED WIRING WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DECOMPOSITION WAS REPORTED DURING FOLLOW-UP. THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) INITIALLY REPORTED THAT PHASE 1 OF THE RO SYSTEM WAS TAKING A LONG TIME TO COMPLETE HEAT DISINFECTION AND THE ERROR CODE W¿02¿52¿03 WAS RECEIVED WITH THE MESSAGE "HEAT DISINFECTION STOPPED." DURING FURTHER TROUBLESHOOTING IT WAS REPORTED THAT HEAT DISINFECTION HAD NOT COMPLETED FOR OVER A YEAR. FRESENIUS TECHNICAL SERVICES RECOMMENDED REDUCING THE RING RETURN PRESSURE AT THE VR94'S AND REATTEMPTING HEAT DISINFECTION, CHECKING PUMP DIRECTION, HEATER AMPERAGES, AND INCREASING THE FEED TEMPERATURE MAX AS NEEDED. DURING INITIAL FOLLOW-UP THE ATOM REPORTED THAT THE POWER SWITCH, THERMO SWITCH, AND WIRING HARNESS WERE REPLACED DURING REPAIR. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS OF THE REPORTED THERMAL DAMAGE ARE AVAILABLE FOR REVIEW. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE COMPLAINT INVESTIGATION DETERMINED THAT THE LIKELY CAUSE OF THE THERMAL DAMAGE WAS A LOOSE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. IN SUCH AN INSTANCE THE PUMP WILL RUN ONLY WITH TWO LINE CONDUCTORS, RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH CAN GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED FOR THIS KNOWN FAILURE. THE WIRING WAS REDESIGNED AND RELEASED. THE DEVICE WAS BUILT BEFORE THE IMPROVEMENT OF THE DESIGN. IN THIS INSTANCE THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE MOTOR PROTECTION SWITCH AND BLACK CONNECTION WIRES AGAINST THE IMPROVED DESIGN IN STAGE 1 AND STAGE 2.

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 AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS THAT CHARRED WIRING WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE THERMAL DECOMPOSITION WAS REPORTED DURING FOLLOW-UP. THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) INITIALLY REPORTED THAT PHASE 1 OF THE RO SYSTEM WAS TAKING A LONG TIME TO COMPLETE HEAT DISINFECTION AND THE ERROR CODE W¿02¿52¿03 WAS RECEIVED WITH THE MESSAGE "HEAT DISINFECTION STOPPED." DURING FURTHER TROUBLESHOOTING IT WAS REPORTED THAT HEAT DISINFECTION HAD NOT COMPLETED FOR OVER A YEAR. FRESENIUS TECHNICAL SERVICES RECOMMENDED REDUCING THE RING RETURN PRESSURE AT THE VR94'S AND REATTEMPTING HEAT DISINFECTION, CHECKING PUMP DIRECTION, HEATER AMPERAGES, AND INCREASING THE FEED TEMPERATURE MAX AS NEEDED. DURING INITIAL FOLLOW-UP THE ATOM REPORTED THAT THE POWER SWITCH, THERMO SWITCH, AND WIRING HARNESS WERE REPLACED DURING REPAIR. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS OF THE REPORTED THERMAL DAMAGE ARE AVAILABLE FOR REVIEW. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED.