AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING AFTER THE BIOMED CONTACTED FRESENIUS FOR ASSISTANCE WITH RESTARTING THE RO SYSTEM AND STARTING THE P1 WHEN A W¿02¿50¿17 CONCENTRATE PRESSURE TOO LOW MESSAGE WAS RECEIVED. THE BLACK WIRES THAT CONNECT THE MOTOR PROTECTION SWITCH TO THE CONTACTOR IN STAGE 1 HAD BURN MARKS AND MISSING WIRE INSULATION. BURN MARKS WERE ALSO PRESENT ON THE INSULATION ON THE LINE POWER CABLE FEMALE SPADE FITTINGS. WIRES WERE BORROWED FROM STAGE 2 AND THE SYSTEM WAS ABLE TO RUN IN EMERGENCY MODE STAGE 1 UNTIL SPARE PARTS COULD BE ACQUIRED. A BLOWN FUSE WAS ALSO IDENTIFIED IN THE SERVICE DISCONNECT. THE BLOWN FUSE (NOT A VIVONIC PRODUCT) WAS REPLACED TO ADDRESS THIS ISSUE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE DETERMINED THERMAL DAMAGE CAN BE CONFIRMED BY THE PICTURES IN THE INTAKE INFORMATION. THE MOST LIKELY FAILURE CAUSE FOR THE DETERMINED THERMAL DAMAGE WAS A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASES AND THE PUMP CURRENT LEADS TO AN INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. AS A CONSEQUENCE THE MOTOR PROTECTION SWITCH COULD TRIP AND COULD INTERRUPT DEVICE OPERATION. THE DETERMINED THERMAL DAMAGE IS KNOWN. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. A NEW WIRING DESIGN WAS RELEASED. THE DEVICE WAS BUILT BEFORE IMPROVEMENT OF THE WIRING DESIGN. ACCORDING TO THE INTAKE INFORMATION THE ISSUE WAS SOLVED BY TEMPORARILY USING THE WIRING FROM STAGE 2. 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 THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING AFTER THE BIOMED CONTACTED FRESENIUS FOR ASSISTANCE WITH RESTARTING THE RO SYSTEM AND STARTING THE P1 WHEN A W¿02¿50¿17 CONCENTRATE PRESSURE TOO LOW MESSAGE WAS RECEIVED. THE BLACK WIRES THAT CONNECT THE MOTOR PROTECTION SWITCH TO THE CONTACTOR IN STAGE 1 HAD BURN MARKS AND MISSING WIRE INSULATION. BURN MARKS WERE ALSO PRESENT ON THE INSULATION ON THE LINE POWER CABLE FEMALE SPADE FITTINGS. WIRES WERE BORROWED FROM STAGE 2 AND THE SYSTEM WAS ABLE TO RUN IN EMERGENCY MODE STAGE 1 UNTIL SPARE PARTS COULD BE ACQUIRED. A BLOWN FUSE WAS ALSO IDENTIFIED IN THE SERVICE DISCONNECT. THE BLOWN FUSE (NOT A VIVONIC PRODUCT) WAS REPLACED TO ADDRESS THIS ISSUE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.