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 THERMAL DAMAGE WAS IDENTIFIED ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WAS EVIDENCE OF BURN MARKS PRESENT ON THE WIRING HARNESS HOUSING AND POWER SUPPLY. THERE IS NO DISCOLORATION OF THE MOTOR PROTECTION SWITCH. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE THERMAL DAMAGE WAS IDENTIFIED AFTER POWER WAS LOST ON THE RO SYSTEM. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING HOWEVER A BURNING SMELL WAS OBSERVED AFTER LIFTING TO STAGE 1 HOOD. THERE WERE NO ALARM CODES ASSOCIATED WITH THE THERMAL DAMAGE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS ON THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. ONE (L1) FUSE WAS FOUND TO BE BLOWN INSIDE THE BREAKER. THE FUSE ALONG WITH THE MOTOR PROTECTION SWITCH, POWER SUPPLY WIRING HARNESS, AND MOTHERBOARD WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. THE REPORTED ISSUE OCCURRED PRIOR TO CLINIC HOURS. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER DETERMINED THAT THE THERMAL DAMAGE AT THE WIRING OF THE MOTOR PROTECTION SWITCH WAS MOST LIKELY CAUSED BY A BAD ELECTRICAL CONTACT. INSUFFICIENT CONTACT PRESSURE BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS ON THE MOTOR PROTECTION SWITCH RESULTS IN BAD ELECTRICAL CONTACT. THE BAD ELECTRICAL CONTACT RESULTED IN A HIGH CONTACT RESISTANCE AND IN COMBINATION WITH THE HIGH PUMP MOTOR CURRENT, A HIGH THERMAL LOAD/STRESS ON THE WIRING OCCURRED. AS A RESULT THE WIRING GETS DISCOLORED AND COULD CHAR. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE WIRING WAS CHANGED. THE AFFECTED DEVICE WAS BUILT BEFORE THE IMPLEMENTATION OF CORRECTIVE ACTIONS. IN THIS PARTICULAR CASE, THE FUSE WITHIN THE LOCAL POWER SUPPLY, MOTOR PROTECTION SWITCH, POWER SUPPLY, WIRING HARNESS, AND MOTHERBOARD WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS RECOMMENDED THAT THE FUSES IN THE LOCAL POWER SUPPLY BE CHECKED. FURTHERMORE, THE CONNECTION WIRES, POWER CORDS AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 SHOULD BE REPLACED TO PREVENT FURTHER ISSUES.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WAS EVIDENCE OF BURN MARKS PRESENT ON THE WIRING HARNESS HOUSING AND POWER SUPPLY. THERE IS NO DISCOLORATION OF THE MOTOR PROTECTION SWITCH. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE THERMAL DAMAGE WAS IDENTIFIED AFTER POWER WAS LOST ON THE RO SYSTEM. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING HOWEVER A BURNING SMELL WAS OBSERVED AFTER LIFTING TO STAGE 1 HOOD. THERE WERE NO ALARM CODES ASSOCIATED WITH THE THERMAL DAMAGE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS ON THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. ONE (L1) FUSE WAS FOUND TO BE BLOWN INSIDE THE BREAKER. THE FUSE ALONG WITH THE MOTOR PROTECTION SWITCH, POWER SUPPLY WIRING HARNESS, AND MOTHERBOARD WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. THE REPORTED ISSUE OCCURRED PRIOR TO CLINIC HOURS. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.