AQUABPLUS, B2, HF 1000 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 THERMAL DAMAGE WAS IDENTIFIED ON THE FRONT POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THAT THE SWITCH OVERHEATED AND POPPED THE BREAKER. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUES. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED CONFIRMED THAT THERE WAS THERMAL DAMAGE TO THE SWITCH AND CONNECTED WIRING. THE BIOMED BELIEVED THE CAUSE OF THE REPORTED FAILURE WAS A LOOSE OR POOR CONNECTION AT THE CONNECTION POINT. THE PARTS APPEARED CHARRED AND BLACKENED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ASSOCIATED ALARMS. THE BIOMED ALSO CONFIRMED THAT THE THERMAL OVERLOAD RELAY IN STAGE 1 HAD TRIPPED. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES NOR STORMS ON OR AROUND THE REPORTED EVENT DATE. THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE WAS RETURNED TO SERVICE FOLLOWING REPAIR. IT WAS CONFIRMED THAT SAMPLES WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE FRONT POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED STATED THAT THE SWITCH OVERHEATED AND POPPED THE BREAKER. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUES. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED CONFIRMED THAT THERE WAS THERMAL DAMAGE TO THE SWITCH AND CONNECTED WIRING. THE BIOMED BELIEVED THE CAUSE OF THE REPORTED FAILURE WAS A LOOSE OR POOR CONNECTION AT THE CONNECTION POINT. THE PARTS APPEARED CHARRED AND BLACKENED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO ASSOCIATED ALARMS. THE BIOMED ALSO CONFIRMED THAT THE THERMAL OVERLOAD RELAY IN STAGE 1 HAD TRIPPED. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES NOR STORMS ON OR AROUND THE REPORTED EVENT DATE. THE SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE WAS RETURNED TO SERVICE FOLLOWING REPAIR. IT WAS CONFIRMED THAT SAMPLES WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER PHOTOGRAPHS OF THE REPORTED ISSUE WERE PROVIDED. THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION AND SAMPLE PHOTOGRAPHS. THE COMPLAINT INVESTIGATION DETERMINED THAT THE LIKELY CAUSE OF THE THERMAL DAMAGE WAS A LOOSE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. IN SUCH AN INSTANCE THE PUMP WILL RUN ONLY WITH TWO LINE CONDUCTORS, RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH CAN GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. IN THIS INSTANCE THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE MOTOR PROTECTION SWITCH AND BLACK CONNECTION WIRES AGAINST THE IMPROVED DESIGN IN STAGE 1 AND STAGE 2.