AQUABPLUS, B2, HF 2000 KIT

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 CABLES ON THE POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ARE BURNED. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED STATED THAT A POWER SURGE OCCURRED. PART NUMBERS FOR A REPLACEMENT POWER SWITCH, CONTACTOR, AND WIRING HARNESS WERE PROVIDED. ADDITIONAL INFORMATION WAS PROVIDED DURING FOLLOW-UP. THE REPORTED THERMAL DAMAGE WAS IDENTIFIED DURING MACHINE REPAIR. THE RO SYSTEM WAS INITIALLY EVALUATED WHEN THE STAFF ARRIVED AT THE START OF THE DAY AND THE SYSTEM WAS POWERED OFF. UPON REMOVING THE STAGE 1 HOOD A BURNING SMELL WAS NOTED. THERE WAS NO OBSERVED SMOKE, SPARK, OR FLAME. THERE WERE NO BLOWN FUSES. CABLE CONNECTIONS L1, L2, AND L3 OF THE STAGE 1 MOTOR PROTECTION SWITCH APPEARED SCORCHED. L1 AND L2 WERE MELTED TO THE PROBE. THE CONTACTOR HAD SOME CHARRING. THE WIRING WAS ALSO EXPOSED. THE BIOMED BELIEVED THE EXPOSED WIRING ALSO COULD HAVE RESULTED IN ARCING. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. IT WAS UNKNOWN WHETHER THE THERMAL OVERLOAD RELAY HAD TRIPPED. THE BIOMED STATED THAT THERE WERE A POWER SURGE HOWEVER THE FACILITY IS EQUIPPED WITH A GENERATOR SO POWER LOSS WAS MOMENTARY. THE MOTOR PROTECTION SWITCH, CONTACTOR, AND WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. THE SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT CABLES ON THE POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ARE BURNED. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE BIOMED STATED THAT A POWER SURGE OCCURRED. PART NUMBERS FOR A REPLACEMENT POWER SWITCH, CONTACTOR, AND WIRING HARNESS WERE PROVIDED. ADDITIONAL INFORMATION WAS PROVIDED DURING FOLLOW-UP. THE REPORTED THERMAL DAMAGE WAS IDENTIFIED DURING MACHINE REPAIR. THE RO SYSTEM WAS INITIALLY EVALUATED WHEN THE STAFF ARRIVED AT THE START OF THE DAY AND THE SYSTEM WAS POWERED OFF. UPON REMOVING THE STAGE 1 HOOD A BURNING SMELL WAS NOTED. THERE WAS NO OBSERVED SMOKE, SPARK, OR FLAME. THERE WERE NO BLOWN FUSES. CABLE CONNECTIONS L1, L2, AND L3 OF THE STAGE 1 MOTOR PROTECTION SWITCH APPEARED SCORCHED. L1 AND L2 WERE MELTED TO THE PROBE. THE CONTACTOR HAD SOME CHARRING. THE WIRING WAS ALSO EXPOSED. THE BIOMED BELIEVED THE EXPOSED WIRING ALSO COULD HAVE RESULTED IN ARCING. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. IT WAS UNKNOWN WHETHER THE THERMAL OVERLOAD RELAY HAD TRIPPED. THE BIOMED STATED THAT THERE WERE A POWER SURGE HOWEVER THE FACILITY IS EQUIPPED WITH A GENERATOR SO POWER LOSS WAS MOMENTARY. THE MOTOR PROTECTION SWITCH, CONTACTOR, AND WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. THE SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

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 AND SAMPLE PHOTOGRAPHS. 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 STAGE 1 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.