AQUABPLUS, B2, HF 1000 KIT

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED CONTACTED FRESENIUS FOR ASSISTANCE AFTER THE RO SYSTEM ALARMED WITH ERROR "F-04-51-03 FAILURE: T1 TEST P-ES SWITCH DEFECTIVE" DURING THE T1 TEST. THE THERMAL OVERLOAD RELAY FOR THE STAGE 2 PUMP HAD TRIPPED. THE RELAY WAS RESET BUT THE T1 TEST FAILURE REOCCURRED. THE BIOMED DISCOVERED SIGNS OF THERMAL DAMAGE ON THE BACK OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) FOR THE CABLE TO THE CONTACTOR. THE BIOMED HAD JUST CHANGED V30 PRIOR TO ENCOUNTERING THIS ISSUE. FRESENIUS IDENTIFIED AN EXTRA SPRING IN V30. THE SPRING WAS REMOVED AND THE T1 TEST PASSED. THE PART NUMBER FOR THE REPLACEMENT CABLE (M11008073ET) WAS PROVIDED. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS A RESULT OF THIS MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED EVENT WAS CONFIRMED BY MEANS OF THE COMPLAINT INTAKE INFORMATION. THE TRIPPED THERMAL OVERLOAD SWITCH, THERMAL DAMAGE OF THE MOTOR PROTECTION SWITCH AND CONNECTED CABLE TO THE CONTACTOR, AS WELL AS ERROR CODE F-04-51-03 - T1-TEST, P-S SWITCH DEFECTIVE ENCOUNTERED DURING TROUBLESHOOTING WERE ALL CONSIDERED WITHIN THE SCOPE OF THIS INVESTIGATION. SUFFICIENT INFORMATION WAS PROVIDED TO DETERMINE THE MOST LIKELY FAILURE CAUSE FOR THIS ISSUE TO BE THE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. A DESIGN IMPROVEMENT WAS MADE TO THE MOTOR PROTECTION SWITCH WHICH IS CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE INTAKE INFORMATION THE ISSUE WAS SOLVED BY REPLACING THE MOTOR PROTECTION SWITCH IN STAGE 1. FURTHERMORE, IT IS RECOMMENDED TO CHECK AND REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO AVOID ADDITIONAL FAILURES.

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

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED CONTACTED FRESENIUS FOR ASSISTANCE AFTER THE RO SYSTEM ALARMED WITH ERROR "F-04-51-03 FAILURE: T1 TEST P-ES SWITCH DEFECTIVE" DURING THE T1 TEST. THE THERMAL OVERLOAD RELAY FOR THE STAGE 2 PUMP HAD TRIPPED. THE RELAY WAS RESET BUT THE T1 TEST FAILURE REOCCURRED. THE BIOMED DISCOVERED SIGNS OF THERMAL DAMAGE ON THE BACK OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) FOR THE CABLE TO THE CONTACTOR. THE BIOMED HAD JUST CHANGED V30 PRIOR TO ENCOUNTERING THIS ISSUE. FRESENIUS IDENTIFIED AN EXTRA SPRING IN V30. THE SPRING WAS REMOVED AND THE T1 TEST PASSED. THE PART NUMBER FOR THE REPLACEMENT CABLE (M11008073ET) WAS PROVIDED. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS A RESULT OF THIS MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.