AQUABPLUS, B2, HF 1000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ENCOUNTERED AN ERROR DURING THE T1 TEST. ERROR ¿F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE¿ WAS RECEIVED. THE SYSTEM WAS EVALUATED AND THE BIOMED NOTED A BLOWN FUSE IN THE EXTERNAL SERVICE DISCONNECT (NOT A FRESENIUS PRODUCT) IN ADDITION TO A TRIPPED THERMAL OVERLOAD RELAY. THE BIOMED REPLACED THE FUSE AND RESET THE THERMAL OVERLOAD RELAY TO RETURN THE SYSTEM TO SERVICE. DURING EVALUATION BURNT WIRES WERE ALSO NOTED ON THE MAINS POWER CABLE. NO OTHER VISUAL INDICATIONS OF THERMAL DECOMPOSITION WERE IDENTIFIED WITHIN THE SYSTEM. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO LOCAL POWER GRID ISSUES, POWER SURGES, OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. A MAINS POWER CABLE WAS ORDERED AND RECEIVED AND WAS PENDING INSTALLATION AT THE TIME OF FOLLOW-UP. THERE WAS NO PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED EVENT CAN BE CONFIRMED FROM THE INFORMATION PROVIDED UPON INTAKE. THE REPORTED EVENT CAN BE ATTRIBUTED TO A BAD ELECTRICAL CONTACT BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED 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 THEN TRIPPED AND INTERRUPTED DEVICE OPERATION. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. A NEW WIRING DESIGN WAS DEVELOPED AND RELEASED. THE DEVICE WAS BUILT BEFORE IMPROVEMENT OF THE WIRING DESIGN AND NO PREVIOUS COMPLAINT RECORD WAS DETERMINED WHERE THE WIRING WAS REPLACED AGAINST THE NEW DESIGN. 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 BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ENCOUNTERED AN ERROR DURING THE T1 TEST. ERROR ¿F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE¿ WAS RECEIVED. THE SYSTEM WAS EVALUATED AND THE BIOMED NOTED A BLOWN FUSE IN THE EXTERNAL SERVICE DISCONNECT (NOT A FRESENIUS PRODUCT) IN ADDITION TO A TRIPPED THERMAL OVERLOAD RELAY. THE BIOMED REPLACED THE FUSE AND RESET THE THERMAL OVERLOAD RELAY TO RETURN THE SYSTEM TO SERVICE. DURING EVALUATION BURNT WIRES WERE ALSO NOTED ON THE MAINS POWER CABLE. NO OTHER VISUAL INDICATIONS OF THERMAL DECOMPOSITION WERE IDENTIFIED WITHIN THE SYSTEM. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO LOCAL POWER GRID ISSUES, POWER SURGES, OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. A MAINS POWER CABLE WAS ORDERED AND RECEIVED AND WAS PENDING INSTALLATION AT THE TIME OF FOLLOW-UP. THERE WAS NO PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.