AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERE WAS THERMAL DAMAGE IDENTIFIED ON THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR AFTER THE RO SYSTEM WAS INITIALLY PULLED FROM SERVICE FOR POWERING OFF UNEXPECTEDLY. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ALARM CODES ASSOCIATED WITH THE POWER ISSUE NOR THE THERMAL DAMAGE. THE BIOMED BELIEVED THE ISSUE OCCURRED AS A RESULT OF LOOSE WIRING WITHIN STAGE 1. THE THERMAL OVERLOAD SWITCH DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE TO RETURN IT TO SERVICE UNTIL THE ARRIVAL AND INSTALLATION OF REPLACEMENT PARTS. THE BIOMED STATED THE MOTOR PROTECTION SWITCH AND WIRING HARNESS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN FULLY RETURNED TO SERVICE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

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 THAT THERE WAS THERMAL DAMAGE IDENTIFIED ON THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR AFTER THE RO SYSTEM WAS INITIALLY PULLED FROM SERVICE FOR POWERING OFF UNEXPECTEDLY. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ALARM CODES ASSOCIATED WITH THE POWER ISSUE NOR THE THERMAL DAMAGE. THE BIOMED BELIEVED THE ISSUE OCCURRED AS A RESULT OF LOOSE WIRING WITHIN STAGE 1. THE THERMAL OVERLOAD SWITCH DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE TO RETURN IT TO SERVICE UNTIL THE ARRIVAL AND INSTALLATION OF REPLACEMENT PARTS. THE BIOMED STATED THE MOTOR PROTECTION SWITCH AND WIRING HARNESS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN FULLY RETURNED TO SERVICE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERE WAS THERMAL DAMAGE IDENTIFIED ON THE THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING IN STAGE 1 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR AFTER THE RO SYSTEM WAS INITIALLY PULLED FROM SERVICE FOR POWERING OFF UNEXPECTEDLY. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ALARM CODES ASSOCIATED WITH THE POWER ISSUE NOR THE THERMAL DAMAGE. THE BIOMED BELIEVED THE ISSUE OCCURRED AS A RESULT OF LOOSE WIRING WITHIN STAGE 1. THE THERMAL OVERLOAD SWITCH DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. NO BLOWN FUSES WERE IDENTIFIED IN THE LOCAL POWER SUPPLY. THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE TO RETURN IT TO SERVICE UNTIL THE ARRIVAL AND INSTALLATION OF REPLACEMENT PARTS. THE BIOMED STATED THE MOTOR PROTECTION SWITCH AND WIRING HARNESS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN FULLY RETURNED TO SERVICE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF DISCOVERING THE THERMAL DAMAGE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE REPORTED THERMAL DAMAGE CAN BE CONFIRMED BASED ON A PHOTOGRAPH PROVIDED BY THE CUSTOMER. THIS IS A KNOWN FAILURE PATTERN. THE LIKELY CAUSE OF THE THERMAL DAMAGE IS A POOR ELECTRICAL CONNECTION OF THE WIRING AT THE MOTOR PROTECTION SWITCH. THE DESIGN OF THE CABLE LUG/BLADE RECEPTACLE IN USE IS NOT ADEQUATE AND CAUSES TRANSITION RESISTANCE. THIS TRANSITION RESISTANCE RESULTS IN HIGH THERMAL ENERGY DURING PUMP OPERATION. THE PRESSURE PUMP CAUSES HIGH CURRENTS DURING PUMP STARTS AND USUAL OPERATION. WITH A HIGHER ELECTRICAL RESISTANCE THE THERMAL LOAD INCREASES UNTIL THE REPORTED HEAT DAMAGE OCCURS. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED TO ADDRESS THIS ISSUE. AN IMPROVED WIRE AND BLADE RECEPTACLE DESIGN IS NOW AVAILABLE. THIS WIRING DESIGN WAS NOT IN USAGE IN THIS CASE AS THE DEVICE WAS MANUFACTURER PRIOR TO THE IMPLEMENTED CORRECTION. IN THIS CASE THE ISSUE WAS RESOLVED WITH REPLACEMENT OF THE MOTOR PROTECTION SWITCH AND THE DEFECTIVE WIRING. A REVIEW OF SIMILAR COMPLAINTS OR THE DEVICE HISTORY RECORD IS NOT REQUIRED.