AQUABPLUS, B2, HF 2500 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

AN ON-CALL BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT STAGE 2 OF A USER FACILITY AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS NOT POWER ON. UPON EVALUATION THE BIOMED DISCOVERED THAT THERMAL DECOMPOSITION WITHIN STAGE 1. L1 AND L2 ON THE MOTOR PROTECTION SWITCH (MPS) SHORTED OUT AND WERE BADLY BURNED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING, HOWEVER A BURNING SMELL WAS PRESENT. THERE WERE NO BLOWN FUSES IDENTIFIED. THE THERMAL OVERLOAD RELAY IN STAGE 2 DID TRIP. IT WAS ALSO NOTED THAT ELECTRICAL STORMS HAD OCCURRED IN THE AREA AROUND THE TIME OF THE REPORTED EVENT. THE STAGE 1 MPS WAS REPLACED. THE THERMAL OVERLOAD RELAY WAS RESET AND THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2 TO BE RETURNED TO SERVICE. A REPLACEMENT WIRING HARNESS WAS ORDERED. THE WIRING HARNESS WILL BE REPLACED UPON ARRIVAL OF THE REPLACEMENT PART. A PHOTOGRAPH OF THE REPORTED THERMAL DAMAGE WAS PROVIDED FOR REVIEW BY THE MANUFACTURER.

Description of Event or Problem

AN ON-CALL BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT STAGE 2 OF A USER FACILITY AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS NOT POWER ON. UPON EVALUATION THE BIOMED DISCOVERED THAT THERMAL DECOMPOSITION WITHIN STAGE 1. L1 AND L2 ON THE MOTOR PROTECTION SWITCH (MPS) SHORTED OUT AND WERE BADLY BURNED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING, HOWEVER A BURNING SMELL WAS PRESENT. THERE WERE NO BLOWN FUSES IDENTIFIED. THE THERMAL OVERLOAD RELAY IN STAGE 2 DID TRIP. IT WAS ALSO NOTED THAT ELECTRICAL STORMS HAD OCCURRED IN THE AREA AROUND THE TIME OF THE REPORTED EVENT. THE STAGE 1 MPS WAS REPLACED. THE THERMAL OVERLOAD RELAY WAS RESET AND THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2 TO BE RETURNED TO SERVICE. A REPLACEMENT WIRING HARNESS WAS ORDERED. THE WIRING HARNESS WILL BE REPLACED UPON ARRIVAL OF THE REPLACEMENT PART. A PHOTOGRAPH OF THE REPORTED THERMAL DAMAGE WAS PROVIDED FOR REVIEW BY THE MANUFACTURER.

Additional Manufacturer Narrative

PLANT INVESTIGATION: A SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE WAS CONFIRMED WITH THE PROVIDED PHOTOGRAPH AND COMPLAINT INFORMATION. THE CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A BAD ELECTRICAL CONTACT BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED TO AN INCREASE IN THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH LIKELY OVERHEATED AND DISCOLORED FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. DUE TO THE BAD ELECTRICAL CONTACT, THE THERMAL OVERLOAD SWITCH OR THE MOTOR PROTECTION SWITCH IN STAGE 1 COULD BECOME UNBALANCED AND TRIP AS INTENDED, BUT WAS NOT REPORTED IN THIS COMPLAINT. POWER FLUCTUATIONS ARE A CONTRIBUTING FACTOR WHICH LED TO THE TRIPPED OVERLOAD RELAY AND IN ADDITION TO THE THERMAL DAMAGE AT THE BLADE RECEPTACLES. TEMPORARY MISSING LINE AND/OR LINE FLUCTUATIONS IN THE LOCAL POWER GRID (BAD ENVIRONMENTAL CONDITIONS) CAUSE AN UNBALANCED LOAD AND THE MOTOR PROTECTION OR THERMAL OVERLOAD RELAY SWITCH TRIPS AS INTENDED. LINE FLUCTUATIONS ALSO CAUSES HIGHER CURRENTS AND HIGHER THERMAL ENERGY AT THE CONTACT PINS OF THE MOTOR PROTECTION SWITCH. AN INADEQUATE DESIGN OF THE ELECTRICAL CONTACT OF THIS APPLICATION IS THE MOST LIKELY FAILURE CAUSE. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING IS DEVELOPED, BUT CURRENTLY NOT RELEASED FOR THE US MARKET. TO RESOLVE THE ISSUE, THE MOTOR PROTECTION SWITCH IN STAGE 1 AND WIRING WERE REPLACED.