AQUABPLUS, B2, HF 500 KIT

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE ORANGE WIRE NEAR THE L2 WIRING APPEARED BURNT AND BLACK. FRESENIUS PROVIDED PART NUMBERS FOR THE MOTOR PROTECTION SWITCH (MPS) (F50005352) AND WIRE SET (F50005231) AS REQUESTED. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP AND ADDITIONAL INFORMATION WAS PROVIDED. THE BIOMED REPORTED THE REPORTED THERMAL DAMAGE WAS OBSERVED ON THE STAGE 1 MPS AND CONNECTED WIRE HARNESS. NO ALARMS WERE ASSOCIATED WITH THE REPORTED ISSUE. A BURNING SMELL WAS NOTED BUT THERE WAS NO REPORTED SMOKE, SPARK, FLAME, OR ARCING. THE THERMAL OVERLOAD RELAY DID NOT TRIP. NO BLOWN FUSES WERE IDENTIFIED. NO LOCAL POWER GRID ISSUES WERE EXPERIENCED ON OR AROUND THE REPORTED EVENT DATE. THE AQUABPLUS WAS PLUGGED INTO ITS OWN BREAKER. THE BIOMED CONFIRMED THAT REPLACEMENTS WERE ORDERED FOR THE MPS AND WIRE HARNESS IN ORDER TO RESOLVE THE REPORTED ISSUE. THE AQUABPLUS HAS BEEN RETURNED TO SERVICE. COMPLAINT SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PERSONAL HARM ASSOCIATED WITH THE REPORTED ISSUE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER AND USED BY THE MANUFACTURER TO CONFIRM THE REPORTED EVENT. THIS FAILURE CAN BE ATTRIBUTED TO BAD ELECTRICAL CONTACTING BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH OVERHEATED AND DISCOLORED FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. DUE TO THE BAD ELECTRICAL CONTACT, THE THERMAL OVERLOAD SWITCH BECAME UNBALANCED AND TRIPPED AS INTENDED. THIS FAILURE IS A KNOWN ISSUE. THE DESIGN OF THE ELECTRICAL CONTACT OF THIS APPLICATION WAS DETERMINED TO BE INADEQUATE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND ARE UNDER IMPLEMENTATION. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING HAS BEEN DEVELOPED BUT IS CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE INTAKE INFORMATION REPLACEMENT PARTS WERE ORDERED. IT IS RECOMMENDED TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE ORANGE WIRE NEAR THE L2 WIRING APPEARED BURNT AND BLACK. FRESENIUS PROVIDED PART NUMBERS FOR THE MOTOR PROTECTION SWITCH (MPS) (B)(6) AND WIRE SET (B)(6) AS REQUESTED. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP AND ADDITIONAL INFORMATION WAS PROVIDED. THE BIOMED REPORTED THE REPORTED THERMAL DAMAGE WAS OBSERVED ON THE STAGE 1 MPS AND CONNECTED WIRE HARNESS. NO ALARMS WERE ASSOCIATED WITH THE REPORTED ISSUE. A BURNING SMELL WAS NOTED BUT THERE WAS NO REPORTED SMOKE, SPARK, FLAME, OR ARCING. THE THERMAL OVERLOAD RELAY DID NOT TRIP. NO BLOWN FUSES WERE IDENTIFIED. NO LOCAL POWER GRID ISSUES WERE EXPERIENCED ON OR AROUND THE REPORTED EVENT DATE. THE AQUABPLUS WAS PLUGGED INTO ITS OWN BREAKER. THE BIOMED CONFIRMED THAT REPLACEMENTS WERE ORDERED FOR THE MPS AND WIRE HARNESS IN ORDER TO RESOLVE THE REPORTED ISSUE. THE AQUABPLUS HAS BEEN RETURNED TO SERVICE. COMPLAINT SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PERSONAL HARM ASSOCIATED WITH THE REPORTED ISSUE.