AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. INITIALLY THE MPS HAD TRIPPED AT STARTUP. DURING EVALUATION TWO FUSES IN THE EXTERNAL DISCONNECT WERE FOUND TO BE BLOWN. TWO OF THE CABLES RUNNING FROM THE MPS TO THE CONTACTOR WERE FOUND TO BE BURNED TO THE POINT THAT THEY HAD ARCED TOGETHER. BARE WIRES WERE EXPOSED. A SINGLE LOOSE WIRE ON THE FEED WAS NOTED TO BE DISCONNECTED. THE BIOMED WAS PROVIDED WITH PART NUMBERS AND ADVISED TO REPLACE THE CABLES AND MPS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP FROM THE BIOMED. IT WAS NOTED THAT THE PARTS APPEARED BURNED AND BLACKENED. THE INSULATION ALSO SUSTAINED HEAT DAMAGE RESULTING IN CHIPPING AND CRACKING WHICH THE BIOMED BELIEVED MAY HAVE CAUSED THE MPS CONNECTIONS TO SHORT. THE BIOMED STATED THAT THE MACHINE ALSO EXPERIENCED A P1 PUMP FAILURE DURING THE T1 TEST AND AN ALARM CODE WAS RECEIVED TO INDICATE THE FAILURE. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, HOWEVER A BURNING SMELL WAS OBSERVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE BIOMED REPLACED THE MPS AND CONNECTED WIRING TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM IS BACK IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO COMPLAINT SAMPLES ARE 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 USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. INITIALLY THE MPS HAD TRIPPED AT STARTUP. DURING EVALUATION TWO FUSES IN THE EXTERNAL DISCONNECT WERE FOUND TO BE BLOWN. TWO OF THE CABLES RUNNING FROM THE MPS TO THE CONTACTOR WERE FOUND TO BE BURNED TO THE POINT THAT THEY HAD ARCED TOGETHER. BARE WIRES WERE EXPOSED. A SINGLE LOOSE WIRE ON THE FEED WAS NOTED TO BE DISCONNECTED. THE BIOMED WAS PROVIDED WITH PART NUMBERS AND ADVISED TO REPLACE THE CABLES AND MPS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP FROM THE BIOMED. IT WAS NOTED THAT THE PARTS APPEARED BURNED AND BLACKENED. THE INSULATION ALSO SUSTAINED HEAT DAMAGE RESULTING IN CHIPPING AND CRACKING WHICH THE BIOMED BELIEVED MAY HAVE CAUSED THE MPS CONNECTIONS TO SHORT. THE BIOMED STATED THAT THE MACHINE ALSO EXPERIENCED A P1 PUMP FAILURE DURING THE T1 TEST AND AN ALARM CODE WAS RECEIVED TO INDICATE THE FAILURE. THE BIOMED ALSO STATED THAT A "TEMPERATURE NOT REACHED" ALARM WAS ENCOUNTERED DURING HEAT DISINFECTION. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, HOWEVER A BURNING SMELL WAS OBSERVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED REPLACED THE MPS AND CONNECTED WIRING TO RESOLVE THE REPORTED THERMAL DAMAGE. THE TEMPERATURE ON THE RO WAS LOWERED TO RESOLVE THE TEMPERATURE ISSUE. THE RO SYSTEM IS BACK IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO COMPLAINT SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

CORRECTION: B3.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE REPORTED THERMAL DAMAGE CAN BE CONFIRMED BASED ON A PHOTOGRAPH PROVIDED BY THE CUSTOMER. THIS IS A KNOWN FAILURE PATTERN. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED TO ADDRESS THIS ISSUE. AN IMPROVED WIRE AND BLADE RECEPTACLE DESIGN IS NOW AVAILABLE. THIS WIRING DESIGN WAS NOT IN USAGE ON THIS DEVICE WHEN THE REPORTED EVENT OCCURRED. IN THIS CASE THE ISSUE WAS RESOLVED WITH REPLACEMENT OF THE MOTOR PROTECTION SWITCH AND THE DEFECTIVE WIRING. A REVIEW OF SIMILAR COMPLAINTS OR THE DEVICE HISTORY RECORD IS NOT REQUIRED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. INITIALLY THE MPS HAD TRIPPED AT STARTUP. DURING EVALUATION TWO FUSES IN THE EXTERNAL DISCONNECT WERE FOUND TO BE BLOWN. TWO OF THE CABLES RUNNING FROM THE MPS TO THE CONTACTOR WERE FOUND TO BE BURNED TO THE POINT THAT THEY HAD ARCED TOGETHER. BARE WIRES WERE EXPOSED. A SINGLE LOOSE WIRE ON THE FEED WAS NOTED TO BE DISCONNECTED. THE BIOMED WAS PROVIDED WITH PART NUMBERS AND ADVISED TO REPLACE THE CABLES AND MPS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP FROM THE BIOMED. IT WAS NOTED THAT THE PARTS APPEARED BURNED AND BLACKENED. THE INSULATION ALSO SUSTAINED HEAT DAMAGE RESULTING IN CHIPPING AND CRACKING WHICH THE BIOMED BELIEVED MAY HAVE CAUSED THE MPS CONNECTIONS TO SHORT. THE BIOMED STATED THAT THE MACHINE ALSO EXPERIENCED A P1 PUMP FAILURE DURING THE T1 TEST AND AN ALARM CODE WAS RECEIVED TO INDICATE THE FAILURE. THE BIOMED ALSO STATED THAT A "TEMPERATURE NOT REACHED" ALARM WAS ENCOUNTERED DURING HEAT DISINFECTION. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, HOWEVER A BURNING SMELL WAS OBSERVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED REPLACED THE MPS AND CONNECTED WIRING TO RESOLVE THE REPORTED THERMAL DAMAGE. THE TEMPERATURE ON THE RO WAS LOWERED TO RESOLVE THE TEMPERATURE ISSUE. THE RO SYSTEM IS BACK IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO COMPLAINT SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

CORRECTION: B5 (REMOVAL OF STATEMENT THAT NO BLOWN FUSES WERE IDENTIFIED).

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. INITIALLY THE MPS HAD TRIPPED AT STARTUP. DURING EVALUATION TWO FUSES IN THE EXTERNAL DISCONNECT WERE FOUND TO BE BLOWN. TWO OF THE CABLES RUNNING FROM THE MPS TO THE CONTACTOR WERE FOUND TO BE BURNED TO THE POINT THAT THEY HAD ARCED TOGETHER. BARE WIRES WERE EXPOSED. A SINGLE LOOSE WIRE ON THE FEED WAS NOTED TO BE DISCONNECTED. THE BIOMED WAS PROVIDED WITH PART NUMBERS AND ADVISED TO REPLACE THE CABLES AND MPS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP FROM THE BIOMED. IT WAS NOTED THAT THE PARTS APPEARED BURNED AND BLACKENED. THE INSULATION ALSO SUSTAINED HEAT DAMAGE RESULTING IN CHIPPING AND CRACKING WHICH THE BIOMED BELIEVED MAY HAVE CAUSED THE MPS CONNECTIONS TO SHORT. THE BIOMED STATED THAT THE MACHINE ALSO EXPERIENCED A P1 PUMP FAILURE DURING THE T1 TEST AND AN ALARM CODE WAS RECEIVED TO INDICATE THE FAILURE. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, HOWEVER A BURNING SMELL WAS OBSERVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED REPLACED THE MPS AND CONNECTED WIRING TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM IS BACK IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO COMPLAINT SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

CORRECTION.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRING IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. INITIALLY THE MPS HAD TRIPPED AT STARTUP. DURING EVALUATION TWO FUSES IN THE EXTERNAL DISCONNECT WERE FOUND TO BE BLOWN. TWO OF THE CABLES RUNNING FROM THE MPS TO THE CONTACTOR WERE FOUND TO BE BURNED TO THE POINT THAT THEY HAD ARCED TOGETHER. BARE WIRES WERE EXPOSED. A SINGLE LOOSE WIRE ON THE FEED WAS NOTED TO BE DISCONNECTED. THE BIOMED WAS PROVIDED WITH PART NUMBERS AND ADVISED TO REPLACE THE CABLES AND MPS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP FROM THE BIOMED. IT WAS NOTED THAT THE PARTS APPEARED BURNED AND BLACKENED. THE INSULATION ALSO SUSTAINED HEAT DAMAGE RESULTING IN CHIPPING AND CRACKING WHICH THE BIOMED BELIEVED MAY HAVE CAUSED THE MPS CONNECTIONS TO SHORT. THE BIOMED STATED THAT THE MACHINE ALSO EXPERIENCED A P1 PUMP FAILURE DURING THE T1 TEST AND AN ALARM CODE WAS RECEIVED TO INDICATE THE FAILURE. THE BIOMED ALSO STATED THAT A "TEMPERATURE NOT REACHED" ALARM WAS ENCOUNTERED DURING HEAT DISINFECTION. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, HOWEVER A BURNING SMELL WAS OBSERVED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED REPLACED THE MPS AND CONNECTED WIRING TO RESOLVE THE REPORTED THERMAL DAMAGE. THE TEMPERATURE ON THE RO WAS LOWERED TO RESOLVE THE TEMPERATURE ISSUE. THE RO SYSTEM IS BACK IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO COMPLAINT SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.