AQUABPLUS, B2, HF 1500 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER BY MEANS OF THE PHOTOGRAPH AND INFORMATION PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THE CAUSE OF THE REPORTED ISSUE TO BE AN INADEQUATE DESIGN OF THE CABLE LUGS, WHICH RESULTED IN BAD ELECTRICAL CONTACTING AT THE CABLE/CABLE LUG ATTACHED TO THE MOTOR PROTECTION SWITCH. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED. A DESIGN CHANGE FOR A DIFFERENT MOTOR PROTECTION SWITCH TYPE AND ELECTRICAL CONNECTION IS GOING TO BE IMPLEMENTED. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. ACCORDING TO THE PROVIDED INFORMATION, THE CONCERNED CABLE AND THE MOTOR PROTECTION SWITCH WERE REPLACED TO RESOLVE THE ISSUE. IT IS RECOMMENDED, TO CHECK AND REPLACE IF REQUIRED THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO AVOID ADDITIONAL FAILURES.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS DISCOVERED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. A BURNED WIRE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 1. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING. THE STAFF ARRIVED TO THE CLINIC AND DISCOVERED THE RO SYSTEM WAS POWERED OFF. UPON INITIATING THE T1 TEST, THE MPS TRIPPED. NO ERROR CODES WERE RECEIVED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, OR FLAME. THE BIOMED ALSO IDENTIFIED A BLOWN FUSE WITHIN THE EXTERNAL SERVICE DISCONNECT (NOT A VIVONIC PRODUCT). THE BLOWN FUSE AND MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS REGARDING THIS ISSUE.

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 BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS DISCOVERED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. A BURNED WIRE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) IN STAGE 1. THE REPORTED ISSUE WAS DISCOVERED DURING TROUBLESHOOTING. THE STAFF ARRIVED TO THE CLINIC AND DISCOVERED THE RO SYSTEM WAS POWERED OFF. UPON INITIATING THE T1 TEST, THE MPS TRIPPED. NO ERROR CODES WERE RECEIVED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, OR FLAME. THE BIOMED ALSO IDENTIFIED A BLOWN FUSE WITHIN THE EXTERNAL SERVICE DISCONNECT (NOT A VIVONIC PRODUCT). THE BLOWN FUSE AND MPS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS REGARDING THIS ISSUE.