AQUABPLUS 3000 B2 2500

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 AREA TECHNICAL OPERATIONS MANAGER (ATOM) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT ERROR W-02-51-03 - CONCENTRATE PRESSURE TOO LOW WAS RECEIVED IN SUPPLY MODE. THE STAGE 2 PUMP WAS NOT RUNNING. THE WIRES AT THE BACK OF THE MOTOR PROTECTION SWITCH (MPS) WERE CHECKED. WHEN THE L1 WIRE WAS MOVED, A SMALL SPARK WAS NOTED AS THE PUMP ATTEMPTED TO RUN AND THE MPS TRIPPED (GREEN BUTTON POPPED OUT). THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE ATOM WAS ADVISED TO REPLACE THE MPS AND VERIFY THAT THERE WERE NO ISSUES WITH THE L1, L2, OR L3 CONNECTIONS TO THE SWITCH. THE ATOM PROVIDED ADDITIONAL INFORMATION DURING FOLLOW-UP. THE MPS WAS FOUND SHORTED AND THERE WAS A SPARK WHEN ATTEMPTING TO VERIFY THAT WIRES WERE FIRMLY CONNECTED. THE ATOM STATED THAT NO THERMAL DAMAGE WAS IDENTIFIED. NO PARTS APPEARED BURNED, CHARRED, MELTED, OR BLACKENED. THE MPS WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. NO PARTS OR PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. THERE WAS NO PATIENT INVOLVEMENT OR PERSONAL HARM ASSOCIATED WITH THE REPORTED ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PHOTOGRAPHS OR SAMPLES WERE PROVIDED TO THE MANUFACTURER FOR REVIEW. HOWEVER, THE MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED ISSUE WITH THE AVAILABLE INFORMATION. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE A BAD ELECTRICAL CONTACT WHICH LED TO INCREASED CONTACT RESISTANCE AND THE PUMP CURRENT LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS/WIRING AT THE MOTOR PROTECTION SWITCH OVERHEATED AND WERE DISCOLORED/DAMAGED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. DUE TO THE BAD ELECTRICAL CONTACT A MAINS LINE COULD ALSO BE MISSING AND THE THERMAL OVERLOAD SWITCH OR THE MOTOR PROTECTION SWITCH (DEPENDING ON THE OPERATION MODE) COULD LOAD UNBALANCED AND TRIP OR BECOME DAMAGED. AS A CONSEQUENCE THE DEVICE OPERATION COULD BE INTERRUPTED AND ERRORS COULD BE TRIGGERED. IN THIS CASE, ERROR CODE W-02-51-03 WAS REPORTED. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. AN IMPROVEMENT WAS MADE TO THE WIRING DESIGN OF THE SWITCH. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. ACCORDING TO THE INTAKE INFORMATION, THE MOTOR PROTECTION SWITCH WAS REPLACED.

Description of Event or Problem

THE AREA TECHNICAL OPERATIONS MANAGER (ATOM) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT ERROR W-02-51-03 - CONCENTRATE PRESSURE TOO LOW WAS RECEIVED IN SUPPLY MODE. THE STAGE 2 PUMP WAS NOT RUNNING. THE WIRES AT THE BACK OF THE MOTOR PROTECTION SWITCH (MPS) WERE CHECKED. WHEN THE L1 WIRE WAS MOVED A SMALL SPARK WAS NOTED AS THE PUMP ATTEMPTED TO RUN AND THE MPS TRIPPED (GREEN BUTTON POPPED OUT). THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE ATOM WAS ADVISED TO REPLACE THE MPS AND VERIFY THAT THERE WERE NO ISSUES WITH THE L1, L2, OR L3 CONNECTIONS TO THE SWITCH. THE ATOM PROVIDED ADDITIONAL INFORMATION DURING FOLLOW-UP. THE MPS WAS FOUND SHORTED AND THERE WAS A SPARK WHEN ATTEMPTING TO VERIFY THAT WIRES WERE FIRMLY CONNECTED. THE ATOM STATED THAT NO THERMAL DAMAGE WAS IDENTIFIED. NO PARTS APPEARED BURNED, CHARRED, MELTED, OR BLACKENED. THE MPS WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS RETURNED TO FULL SERVICE FOLLOWING REPAIR. NO PARTS OR PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. THERE WAS NO PATIENT INVOLVEMENT OR PERSONAL HARM ASSOCIATED WITH THE REPORTED ISSUE.