AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. BURNT WIRING WAS DISCOVERED AT THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 1. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR WHEN THE MACHINE WAS EVALUATED FOR A CONCENTRATE PRESSURE ISSUE. THE BIOMED STATED THAT THE BURNT WIRES AND MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM IS CURRENTLY IN SERVICE. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MACHINE FILES WERE PROVIDED TO THE MANUFACTURER FOR REVIEW. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED EVENT CAN BE CONFIRMED BY PICTURES IN THE INTAKE SECTION. THE FAILURE PATTERN THERMAL DAMAGE/DECOMPOSITION WAS FOUND IN STAGE 1 DURING TROUBLESHOOTING/REPAIR OF THE ERROR CODE ¿W-02-51-03: CONCENTRATE PRESSURE (P-CS) TOO LOW.¿ THE THERMAL DAMAGE WAS LIKELY CAUSED BY 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/WIRING AT THE MOTOR PROTECTION SWITCH OVERHEATED AND DISCOLORED/DAMAGED FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING WAS DEVELOPED, BUT IS CURRENTLY NOT RELEASED FOR THE US MARKET. THE AFFECTED AQUABPLUS IN THIS COMPLAINT WAS MANUFACTURED BEFORE THE CORRECTIVE ACTION OF THE CAPA PROJECT WAS IMPLEMENTED IN THE SERIES PRODUCTION. ACCORDING TO THE INTAKE INFORMATION THE ISSUE WAS SOLVED BY REPLACING THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE ALSO THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 2, TO AVOID ADDITIONAL FAILURES.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. BURNT WIRING WAS DISCOVERED AT THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 1. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR WHEN THE MACHINE WAS EVALUATED FOR A CONCENTRATE PRESSURE ISSUE. THE BIOMED STATED THAT THE BURNT WIRES AND MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM IS CURRENTLY IN SERVICE. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MACHINE FILES WERE PROVIDED TO THE MANUFACTURER FOR REVIEW. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS ISSUE.

Additional Manufacturer Narrative

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