AQUABPLUS, B2, HF 2000 KIT

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

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRES WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE BURNED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED AFTER THE RO SYSTEM FAILED THE T1 TEST. ERROR "F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE" WAS RECEIVED. A BLOWN FUSE WAS ALSO IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE STAGE 1 MPS AND WIRING HARNESS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE BLOWN FUSE WAS REPLACED. THE RO SYSTEM WAS RETURNED TO SERVICE. A PHOTOGRAPH WAS REPORTED TO BE AVAILABLE FOR REVIEW. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR 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 MANUFACTURER CONFIRMED THE REPORTED ISSUE BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THAT THE THERMAL DAMAGE OCCURRED DUE TO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS AT AS THE RESULT OF POOR ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE HIGH CURRENTS RESULTED IN THERMAL DAMAGE TO THE THE WIRES AND CABLE LUGS. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. THE CRIMPED CABLE LUG HAS BEEN RE-DESIGNED. THE DESIGN CHANGE PROCESS IS ONGOING AND NOT COMPLETED YET. THE NEW DESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. THE MACHINE WAS MANUFACTURED PRIOR TO RELEASE OF THE RE-DESIGNED CRIMPED CABLE LUG. A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. IN THIS CASE, THE SWITCH AND WIRING HAVE BEEN REPLACED TO RESOLVE THE REPORTED ISSUE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) AND CONNECTED WIRES WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE BURNED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE REPORTED ISSUE WAS DISCOVERED AFTER THE RO SYSTEM FAILED THE T1 TEST. ERROR ¿F¿04¿50¿04 FAILURE: T1 TEST, PUMP P1 DEFECTIVE¿ WAS RECEIVED. A BLOWN FUSE WAS ALSO IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE STAGE 1 MPS AND WIRING HARNESS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE BLOWN FUSE WAS REPLACED. THE RO SYSTEM WAS RETURNED TO SERVICE. A PHOTOGRAPH WAS REPORTED TO BE AVAILABLE FOR REVIEW. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.