AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A BURNT WIRE WAS IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE WIRE WAS RED AND BLUE AND CONNECTED TO THE MOTHER BOARD IN STAGE 1. THE WIRE HAD BURNT SO BADLY THAT IT NEARLY FUSED WITH THE MOTHERBOARD. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED WAS CONTACTED BY THE FACILITY AFTER POWER WAS LOST ON THE RO SYSTEM. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ALARM CODES ASSOCIATED WITH THE THERMAL DAMAGE. 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. IT WAS CONFIRMED THAT A BLOWN FUSE WAS IDENTIFIED IN THE POWER DISTRIBUTION CENTER. THE BLOWN FUSE AND THE BURNT WIRE (WIRING HARNESS) WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. THE COMPLAINT SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER WHICH THE MANUFACTURER USED ALONG WITH THE PROVIDED INFORMATION TO CONFIRM THE REPORTED THERMAL DAMAGE. THE THERMAL DAMAGE OF THE WIRING OF THE MOTOR PROTECTION SWITCH AND THE 24V CONNECTOR WERE MOST LIKELY CAUSED BY POOR ELECTRICAL. INSUFFICIENT CONTACT PRESSURE RESULTED IN A HIGH CONTACT RESISTANCE AND 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. THE FUSE WITHIN THE LOCAL POWER SUPPLY AND WIRING HARNESS 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.

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 A BURNT WIRE WAS IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE WIRE WAS RED AND BLUE AND CONNECTED TO THE MOTHER BOARD IN STAGE 1. THE WIRE HAD BURNT SO BADLY THAT IT NEARLY FUSED WITH THE MOTHERBOARD. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR. THE BIOMED WAS CONTACTED BY THE FACILITY AFTER POWER WAS LOST ON THE RO SYSTEM. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ALARM CODES ASSOCIATED WITH THE THERMAL DAMAGE. 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. IT WAS CONFIRMED THAT A BLOWN FUSE WAS IDENTIFIED IN THE POWER DISTRIBUTION CENTER. THE BLOWN FUSE AND THE BURNT WIRE (WIRING HARNESS) WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. THE COMPLAINT SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.