AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE MOTOR PROTECTION SWITCH (MPS) WAS BURNED AND THE CONNECTED WIRING WAS CHARRED. THE THERMAL DAMAGE WAS IDENTIFIED DURING TROUBLESHOOTING. THE ATOM INITIALLY CONTACTED TECHNICAL SERVICES AFTER THE RO SYSTEM FAILED THE T1 TEST. ERROR CODE W¿02¿51¿03 WAS RECEIVED WITH THE MESSAGE "CONCENTRATE PRESSURE TOO LOW." THE ATOM WAS ADVISED TO CHECK THE CONCENTRATION PRESSURE AND ITS PARAMETERS. THE CONCENTRATION PRESSURE WAS SET TO 4 AND THE MINIMAL ALARM LIMIT IS 7. THE ATOM WAS ADVISED TO ADJUST THE MINIMAL CONCENTRATION TO 3. THE T1 TEST WAS PERFORMED AGAIN AND PASSED. THE ATOM WAS ADVISED TO RUN A SECOND T1 TEST. THE T1 TEST FAILED. ERROR CODE F-04-51-04 WAS RECEIVED WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE. THE ATOM WAS ADVISED TO CHECK THE MPS WHICH IS WHEN THE REPORTED THERMAL DAMAGE WAS DISCOVERED. THE ATOM WAS ADVISED TO REPLACE THE MPS AND WIRING. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE ATOM STATED THE THERMAL DAMAGE WAS LOCATED IN STAGE 2. THERE WAS NO OBSERVED, SMOKE, SPARK, FLAME, OR ARCING HOWEVER A BURNING SMELL WAS NOTED. THE THERMAL OVERLOAD RELAY ALSO TRIPPED. THERE WERE NO BLOWN FUSES FOUND IN THE LOCAL POWER SUPPLY. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO POWER OUTAGES OR STORMS AT THE FACILITY ON THE REPORTED EVENT DATE, HOWEVER THE ATOM NOTED THAT POWER OUTAGES ARE COMMON FOR THE AREA. THE MPS WAS REPLACED AND THE UPGRADED WIRING KIT WAS INSTALLED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE SAMPLE WAS REPORTED TO BE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: BASED ON THE PROVIDED PHOTOGRAPH AND INFORMATION, THERMAL DAMAGE OF THE WIRING AT THE MOTOR PROTECTION SWITCH CAN BE CONFIRMED. THE MOST LIKELY FAILURE CAUSE OF THE REPORTED ISSUE IS A MISSING LINE CONDUCTOR DURING PUMP START THAT IS CAUSED BY THE BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE DEVICE WILL RUN WITH ONLY TWO LINE CONDUCTORS CAUSING INCREASED CURRENTS ON THE REMAINING LINE CONDUCTORS AND THE MOTOR PROTECTION SWITCH WILL TRIP FROM THE UNBALANCED LOAD. THE THERMAL DAMAGE AT THE WIRING OF THE MOTOR PROTECTION SWITCH IS ALSO CAUSED BY A BAD ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH. A REVIEW FOR SIMILAR COMPLAINTS IS NOT REQUIRED IN THIS CASE. THIS FAILURE TYPE IS A KNOWN FAILURE. A CAPA HAS BEEN OPENED TO ADDRESS THE DESIGN FLAW OF THE USED BLADE RECEPTACLES, WHICH RESULTS IN A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH PINS, RESULTING IN TRANSITION RESISTANCE AND ULTIMATELY HIGH THERMAL ENERGY AT THE BLADE RECEPTACLES. THE DEVICE WAS BUILT BEFORE AN IMPROVED DESIGN OF THE BLADE RECEPTACLES WAS RELEASED. IT IS RECOMMENDED THAT THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING IN STAGES 1 AND 2 BE REPLACED AGAINST THE IMPROVED DESIGN.

Additional Manufacturer Narrative

CORRECTION: H6 (MEDICAL DEVICE CLINICAL CODE, MEDICAL DEVICE - PROBLEM CODE).

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE MOTOR PROTECTION SWITCH (MPS) WAS BURNED AND THE CONNECTED WIRING WAS CHARRED. THE THERMAL DAMAGE WAS IDENTIFIED DURING TROUBLESHOOTING. THE ATOM INITIALLY CONTACTED TECHNICAL SERVICES AFTER THE RO SYSTEM FAILED THE T1 TEST. ERROR CODE W¿02¿51¿03 WAS RECEIVED WITH THE MESSAGE "CONCENTRATE PRESSURE TOO LOW." THE ATOM WAS ADVISED TO CHECK THE CONCENTRATION PRESSURE AND ITS PARAMETERS. THE CONCENTRATION PRESSURE WAS SET TO 4 AND THE MINIMAL ALARM LIMIT IS 7. THE ATOM WAS ADVISED TO ADJUST THE MINIMAL CONCENTRATION TO 3. THE T1 TEST WAS PERFORMED AGAIN AND PASSED. THE ATOM WAS ADVISED TO RUN A SECOND T1 TEST. THE T1 TEST FAILED. ERROR CODE F-04-51-04 WAS RECEIVED WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE ATOM WAS ADVISED TO CHECK THE MPS WHICH IS WHEN THE REPORTED THERMAL DAMAGE WAS DISCOVERED. THE ATOM WAS ADVISED TO REPLACE THE MPS AND WIRING. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE ATOM STATED THE THERMAL DAMAGE WAS LOCATED IN STAGE 2. THERE WAS NO OBSERVED, SMOKE, SPARK, FLAME, OR ARCING HOWEVER A BURNING SMELL WAS NOTED. THE THERMAL OVERLOAD RELAY ALSO TRIPPED. THERE WERE NO BLOWN FUSES FOUND IN THE LOCAL POWER SUPPLY. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO POWER OUTAGES OR STORMS AT THE FACILITY ON THE REPORTED EVENT DATE, HOWEVER THE ATOM NOTED THAT POWER OUTAGES ARE COMMON FOR THE AREA. THE MPS WAS REPLACED AND THE UPGRADED WIRING KIT WAS INSTALLED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE SAMPLE WAS REPORTED TO BE UNAVAILABLE 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 USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE MOTOR PROTECTION SWITCH (MPS) WAS BURNED AND THE CONNECTED WIRING WAS CHARRED. THE THERMAL DAMAGE WAS IDENTIFIED DURING TROUBLESHOOTING. THE ATOM INITIALLY CONTACTED TECHNICAL SERVICES AFTER THE RO SYSTEM FAILED THE T1 TEST. ERROR CODE W¿02¿51¿03 WAS RECEIVED WITH THE MESSAGE "CONCENTRATE PRESSURE TOO LOW." THE ATOM WAS ADVISED TO CHECK THE CONCENTRATION PRESSURE AND ITS PARAMETERS. THE CONCENTRATION PRESSURE WAS SET TO 4 AND THE MINIMAL ALARM LIMIT IS 7. THE ATOM WAS ADVISED TO ADJUST THE MINIMAL CONCENTRATION TO 3. THE T1 TEST WAS PERFORMED AGAIN AND PASSED. THE ATOM WAS ADVISED TO RUN A SECOND T1 TEST. THE T1 TEST FAILED. ERROR CODE F-04-51-04 WAS RECEIVED WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE ATOM WAS ADVISED TO CHECK THE MPS WHICH IS WHEN THE REPORTED THERMAL DAMAGE WAS DISCOVERED. THE ATOM WAS ADVISED TO REPLACE THE MPS AND WIRING. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE ATOM STATED THE THERMAL DAMAGE WAS LOCATED IN STAGE 2. THERE WAS NO OBSERVED, SMOKE, SPARK, FLAME, OR ARCING HOWEVER A BURNING SMELL WAS NOTED. THE THERMAL OVERLOAD RELAY ALSO TRIPPED. THERE WERE NO BLOWN FUSES FOUND IN THE LOCAL POWER SUPPLY. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO POWER OUTAGES OR STORMS AT THE FACILITY ON THE REPORTED EVENT DATE, HOWEVER THE ATOM NOTED THAT POWER OUTAGES ARE COMMON FOR THE AREA. THE MPS WAS REPLACED AND THE UPGRADED WIRING KIT WAS INSTALLED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE SAMPLE WAS REPORTED TO BE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.