AQUABPLUS, B2, HF 1000 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 REGISTERED NURSE (RN) CONTACTED FRESENIUS TECHNICAL SERVICES AND REPORTED THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODE ¿F-04-51-04: T1 TEST FAILURE. P1S PUMP FAILURE¿ DURING THE T1 TEST. THE RN INITIALLY RECEIVED ERROR CODE ¿F-04-51-03 T1 TEST, P-ES SWITCH DEFECTIVE¿ AND WAS ABLE TO CLEAR THE INITIAL ERROR BY POWER CYCLING THE RO SYSTEM WHEN THE SECOND ALARM WAS RECEIVED. FRESENIUS TECHNICAL SERVICES ADVISED THE RN TO RESET THE MOTOR PROTECTION SWITCH (MPS). THE RN MADE A SUBSEQUENT CALL TO FRESENIUS WHEN ERROR ¿F-04-51-04: T1 TEST FAILURE. P1S PUMP FAILURE¿ REOCCURRED. UPON INSPECTION THE THERMAL OVERLOAD RELAY WAS FOUND TO BE TRIPPED AND THERMAL DAMAGE WAS IDENTIFIED ON THE WIRES GOING TO THE MPS. NO BLOWN FUSES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE FACILITY BIOMEDICAL TECHNICIAN (BIOMED). THERMAL DECOMPOSITION WAS IDENTIFIED ON THE CONNECTION TO THE STAGE 2 MOTOR PROTECTION SWITCH (MPS). THE POWER CORD CONNECTION TO THE SWITCH POSTS APPEARED CHARRED. THERE WAS A BURNING SMELL ASSOCIATED WITH THE REPORTED ISSUE BUT NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE POWER CORD AND CONNECTION TO THE POST OF THE MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS ARE EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT OR PERSONAL HARM ASSOCIATED WITH THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED ISSUE WAS CONFIRMED WITH PHOTOGRAPHS MADE AVAILABLE BY THE CUSTOMER. THE MOST LIKELY FAILURE CAUSE FOR THE FAILURE PATTERN IS 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 FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THE MOTOR PROTECTION SWITCH COULD ALSO LOAD UNBALANCED FROM THIS ISSUE. AS A CONSEQUENCE THE MOTOR PROTECTION SWITCH COULD TRIP AND INTERRUPT DEVICE OPERATION. IN THIS CASE THE ERROR CODE F-04-51-04 T1-TEST, PUMP P1S DEFECTIVE WAS REPORTED. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. AN IMPROVED WIRING DESIGN WAS CREATED AND RELEASED, HOWEVER THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. IT IS RECOMMENDED TO REPLACE THE WIRING AND MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.

Description of Event or Problem

A USER FACILITY REGISTERED NURSE (RN) CONTACTED FRESENIUS TECHNICAL SERVICES AND REPORTED THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODE ¿F-04-51-04: T1 TEST FAILURE. P1S PUMP FAILURE¿ DURING THE T1 TEST. THE RN INITIALLY RECEIVED ERROR CODE ¿F-04-51-03 T1 TEST, P-ES SWITCH DEFECTIVE¿ AND WAS ABLE TO CLEAR THE INITIAL ERROR BY POWER CYCLING THE RO SYSTEM WHEN THE SECOND ALARM WAS RECEIVED. FRESENIUS TECHNICAL SERVICES ADVISED THE RN TO RESET THE MOTOR PROTECTION SWITCH (MPS). THE RN MADE A SUBSEQUENT CALL TO FRESENIUS WHEN ERROR ¿F-04-51-04: T1 TEST FAILURE. P1S PUMP FAILURE¿ REOCCURRED. UPON INSPECTION THE THERMAL OVERLOAD RELAY WAS FOUND TO BE TRIPPED AND THERMAL DAMAGE WAS IDENTIFIED ON THE WIRES GOING TO THE MPS. NO BLOWN FUSES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE FACILITY BIOMEDICAL TECHNICIAN (BIOMED). THERMAL DECOMPOSITION WAS IDENTIFIED ON THE CONNECTION TO THE STAGE 2 MOTOR PROTECTION SWITCH (MPS). THE POWER CORD CONNECTION TO THE SWITCH POSTS APPEARED CHARRED. THERE WAS A BURNING SMELL ASSOCIATED WITH THE REPORTED ISSUE BUT NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THE POWER CORD AND CONNECTION TO THE POST OF THE MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PARTS ARE EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT OR PERSONAL HARM ASSOCIATED WITH THE REPORTED ISSUE.