AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SERVICES FOR ASSISTANCE AFTER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM MACHINE FAILED THE T1 TEST. ERROR CODE F¿04¿51¿04 WAS RECEIVED ALONG WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE BIOMED STATED DURING FOLLOW-UP THAT THE ISSUE WAS RESOLVED BY RESETTING THE RO SYSTEM. THE BIOMED WAS ADVISED TO EVALUATE THE MACHINE AND TIGHTEN ALL POSSIBLE LOOSE CABLES THAT COULD BE FOUND INSIDE THE POWER BOX. THE BIOMED STATED THAT WHEN COVER WAS REMOVED FROM STAGE 1 THE L2 CABLE ON THE ON/OFF SWITCH APPEARED TO BE BURNED. THE SWITCH AND CONNECTOR CABLE WERE REPLACED TO RESOLVE THE REPORTED ISSUE. AN ELECTRICAL LEAKAGE TEST WAS ALSO PERFORMED AND PASSED. THE BIOMED CONFIRMED THAT THE RO SYSTEM HAS BEEN OPERATING WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANYONE AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE. NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER. THE FAILURE PATTERN AND CAUSE CAN BE ATTRIBUTED TO A BAD ELECTRICAL CONTACT BETWEEN THE CABLE LUG OF MAINS PHASE L2 AND ITS CONTACT PIN AT THE MOTOR PROTECTION SWITCH. DUE TO THE BAD ELECTRICAL CONTACT, LIKELY MAINS PHASE L2 GOT LOST. THE THERMAL OVERLOAD SWITCH WAS LIKELY TRIGGERED AND TRIPPED AS INTENDED, AS IT WAS LOADED AND UNBALANCED DUE TO THE MISSING MAINS PHASE L2. THE PUMP P1 WOULD THEN BE INOPERABLE DUE TO THE TRIPPED THERMAL OVERLOAD SWITCH AND THE REQUIRED CONCENTRATE PRESSURE P-C WOULD NOT BE EXCEEDED, RESULTING IN ERROR CODE F-04-50-04 - T1-TEST, P1 DEFECTIVE. THE THERMAL DAMAGE OCCURRED DUE TO THE TOO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS BETWEEN THE CABLE LUG OF MAINS PHASE L2 AND ITS CONTACT PIN AT THE MOTOR PROTECTION SWITCH. AS HIGHER CURRENTS OCCUR IN SUCH A SCENARIO, THE WIRE AND CABLE LUG IS EXPOSED TO RESPECTIVELY HIGHER TEMPERATURES , RESULTING IN THE REPORTED THERMAL DAMAGE. THIS IS A KNOWN FAILURE PATTERN. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED. THE CONCERNED DEVICE WAS BUILT BEFORE THE IMPLEMENTATION OF THE CAPA AND WAS STILL EQUIPPED WITH THE OLD DESIGN OF THE CRIMPED CABLE LUGS AT TIME OF THE FAILURE. ACCORDING THE PROVIDED FEEDBACK THE MOTOR PROTECTION SWITCH AND THE CABLE CONNECTOR WERE REPLACED TO SOLVE THE ISSUE .IT IS UNKNOWN IF THE CABLE CONNECTOR IS MEANING ONLY THE CABLE LUG OR THE POWER CORD. IF NOT ALREADY DONE IT IS ALSO RECOMMENDED TO REPLACE THE STAGE 1 POWER CORD AND ALSO THE CONNECTION CABLE BETWEEN MOTOR PROTECTION SWITCH AND CONTACTOR AT STAGE 1 WITH THE NEW AVAILABLE IMPROVED WIRING DESIGN, AS WELL AS THE COMPLETE WIRING ATTACHED TO THE MOTOR PROTECTION SWITCH AT STAGE 2 WITH THE NEW AVAILABLE IMPROVED WIRING DESIGN.