AQUABPLUS, B2, HF 2000 KIT

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.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE MOTOR PROTECTION SWITCHES AND CONNECTED WIRING WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE BURNED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE EVALUATION. THE BIOMED CONTACTED FRESENIUS FOR TROUBLESHOOTING ASSISTANCE AFTER ERROR CODES W¿04¿50¿04 AND F¿04¿50¿04 WERE RECEIVED DURING THE T1 TEST. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THERMAL DAMAGE TO A TERMINAL ON THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 1 WAS NOTED. THE BIOMED DESCRIBED THE TERMINAL AS CHARRED AND DISCOLORED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THERE WAS NO BLOWN FUSES NOTED. THERE WERE NO POWER GRID ISSUES AT THE FACILITY ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED COULD NOT CONFIRM WHETHER THE THERMAL OVERLOAD RELAY WAS TRIPPED. THERE WAS NO HARM TO PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE IN ORDER TO TREAT PATIENTS FOR THE DAY. AFTER CLINIC HOURS THE MPS AND WIRE CONNECTION FROM THE CIRCUIT BREAKER TO THE SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE ARE NO PHOTOGRAPHS OF THE THERMAL DAMAGE AVAILABLE. THE SAMPLES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE MOTOR PROTECTION SWITCHES AND CONNECTED WIRING WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE BURNED. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE EVALUATION. THE BIOMED CONTACTED FRESENIUS FOR TROUBLESHOOTING ASSISTANCE AFTER ERROR CODES W¿04¿50¿04 AND F¿04¿50¿04 WERE RECEIVED DURING THE T1 TEST. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THERMAL DAMAGE TO A TERMINAL ON THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 1 WAS NOTED. THE BIOMED DESCRIBED THE TERMINAL AS CHARRED AND DISCOLORED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THERE WAS NO BLOWN FUSES NOTED. THERE WERE NO POWER GRID ISSUES AT THE FACILITY ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED COULD NOT CONFIRM WHETHER THE THERMAL OVERLOAD RELAY WAS TRIPPED. THERE WAS NO HARM TO PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE IN ORDER TO TREAT PATIENTS FOR THE DAY. AFTER CLINIC HOURS THE MPS AND WIRE CONNECTION FROM THE CIRCUIT BREAKER TO THE SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THERE ARE NO PHOTOGRAPHS OF THE THERMAL DAMAGE AVAILABLE. THE SAMPLES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.