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 DECOMPOSITION WAS DISCOVERED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DURING ANNUAL PREVENTATIVE MAINTENANCE. THE WIRES CONNECTED TO THE POWER BUTTON IN STAGE 1 WERE BURNT. THE BIOMED WAS ADVISED TO CUT BACK THE WIRES TO THE POWER SWITCH TO REMOVE THE BURNT PORTION AND REPLACE THE POWER SWITCH. THE BIOMED WAS ADVISED THAT THE RO SYSTEM COULD BE RETURNED TO PROPER OPERATION IF ANNUAL PM WAS COMPLETED WITHOUT ISSUE. THE BIOMED CALLED AGAIN AND REPORTED THAT THE P1 PUMP WOULD NOT START IN RINSE AND SUPPLY MODES FOLLOWING REPAIR OF THE WIRES AND REPLACEMENT OF THE SWITCH. THE BIOMED WAS ADVISED TO RESET THE BUTTON WITHIN THE BLACK WIRE CONTACTOR BOX. THE BUTTON REMAINED RESET. THE HOOD WAS PLACED DOWN AND THE RO SYSTEM WAS PLACED INTO T1 TESTING. THE P1 PUMP STARTED AS EXPECTED. THE RO SYSTEM PASSED ALL TESTING. THE RO SYSTEM WAS RETURNED TO FULL OPERATION AND IS RUNNING WITHOUT FURTHER ISSUE. THE COMPLAINT SAMPLE WAS DISCARDED AND IS NOT 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 PHOTOGRAPHS WERE PROVIDED WHICH THE MANUFACTURER USED TO CONFIRM THE REPORTED ISSUE. THE MOST LIKELY FAILURE CAUSE FOR THE DETERMINED THERMAL DAMAGE WAS A BAD ELECTRICAL CONTACT 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 BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. AS A CONSEQUENCE THE THERMAL OVERLOAD SWITCH OR THE MOTOR PROTECTION SWITCH COULD TRIP AND INTERRUPT THE DEVICE OPERATION, BUT WAS NOT REPORTED IN THIS CASE. THE DETERMINED THERMAL DAMAGE IS A KNOWN FAILURE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE WIRING WAS REDESIGNED AND RELEASED. THE DEVICE WAS BUILT BEFORE IMPROVEMENT OF THE WIRING DESIGN. ACCORDING TO THE INTAKE INFORMATION, THE ISSUE WAS RESOLVED BY REPLACING THE MOTOR PROTECTION SWITCH AND BY REPAIRING THE WIRING. IT IS RECOMMENDED TO REPLACE THE COMPLETE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS DISCOVERED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DURING ANNUAL PREVENTATIVE MAINTENANCE. THE WIRES CONNECTED TO THE POWER BUTTON IN STAGE 1 WERE BURNT. THE BIOMED WAS ADVISED TO CUT BACK THE WIRES TO THE POWER SWITCH TO REMOVE THE BURNT PORTION AND REPLACE THE POWER SWITCH. THE BIOMED WAS ADVISED THAT THE RO SYSTEM COULD BE RETURNED TO PROPER OPERATION IF ANNUAL PM WAS COMPLETED WITHOUT ISSUE. THE BIOMED CALLED AGAIN AND REPORTED THAT THE P1 PUMP WOULD NOT START IN RINSE AND SUPPLY MODES FOLLOWING REPAIR OF THE WIRES AND REPLACEMENT OF THE SWITCH. THE BIOMED WAS ADVISED TO RESET THE BUTTON WITHIN THE BLACK WIRE CONTACTOR BOX. THE BUTTON REMAINED RESET. THE HOOD WAS PLACED DOWN AND THE RO SYSTEM WAS PLACED INTO T1 TESTING. THE P1 PUMP STARTED AS EXPECTED. THE RO SYSTEM PASSED ALL TESTING. THE RO SYSTEM WAS RETURNED TO FULL OPERATION AND IS RUNNING WITHOUT FURTHER ISSUE. THE COMPLAINT SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.