AQUABPLUS, B2, HF 1500 KIT

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 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 MACHINE WAS MANUFACTURED PRIOR TO RELEASE THE RE-DESIGNED CRIMPED CABLE LUG. A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. THE ISSUE CAN BE SOLVED, IF NOT ALREADY DONE, BY REPLACING THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 TO PREVENT ADDITIONAL FAILURES.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SERVICES AND REPORTED THAT THE STAGE 1 POWER SWITCH ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM TRIPS AT POWER ON AND PRIOR TO THE P1 PUMP STARTING. UPON EVALUATION INDICATIONS OF THERMAL DECOMPOSITION WERE NOTED ON THE BLACK AND ORANGE WIRES. AN ELECTRICAL SMELL WAS ALSO PRESENT. FRESENIUS ADVISED THE BIOMED TO TEMPORARILY TAPE THE BLACK AND ORANGE WIRES AS NEEDED. STAGE 1 WAS RESTARTED AND TRIPPED AGAIN. IT WAS ALSO DISCOVERED THAT THE THERMAL OVERLOAD RELAY HAD TRIPPED AND COULD NOT BE RESET. FRESENIUS PROVIDED PART NUMBERS AND ADVISED THE BIOMED TO REPLACE THE THERMAL OVERLOAD RELAY, CONTACTOR, AND POWER CABLE. THE BIOMED WAS ADVISED TO PLACE STAGE 2 IN EMERGENCY MODE. LIMITED INFORMATION WAS AVAILABLE UPON FOLLOW-UP WITH THE BIOMED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING, HOWEVER A BURNING SMELL WAS NOTED. THE SWITCH WAS REPLACED WHICH RESOLVED THE REPORTED ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. NO PARTS ARE BEING RETURNED FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SERVICES AND REPORTED THAT THE STAGE 1 POWER SWITCH ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM TRIPS AT POWER ON AND PRIOR TO THE P1 PUMP STARTING. UPON EVALUATION INDICATIONS OF THERMAL DECOMPOSITION WERE NOTED ON THE BLACK AND ORANGE WIRES. AN ELECTRICAL SMELL WAS ALSO PRESENT. FRESENIUS ADVISED THE BIOMED TO TEMPORARILY TAPE THE BLACK AND ORANGE WIRES AS NEEDED. STAGE 1 WAS RESTARTED AND TRIPPED AGAIN. IT WAS ALSO DISCOVERED THAT THE THERMAL OVERLOAD RELAY HAD TRIPPED AND COULD NOT BE RESET. FRESENIUS PROVIDED PART NUMBERS AND ADVISED THE BIOMED TO REPLACE THE THERMAL OVERLOAD RELAY, CONTACTOR, AND POWER CABLE. THE BIOMED WAS ADVISED TO PLACE STAGE 2 IN EMERGENCY MODE. LIMITED INFORMATION WAS AVAILABLE UPON FOLLOW-UP WITH THE BIOMED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING, HOWEVER A BURNING SMELL WAS NOTED. THE SWITCH WAS REPLACED WHICH RESOLVED THE REPORTED ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. NO PARTS ARE BEING RETURNED 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

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