AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER SAMPLE PHOTOGRAPHS 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.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED THERMAL DAMAGE WAS IDENTIFIED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR TROUBLESHOOTING ASSISTANCE AFTER RECEIVING ERROR F¿04¿50¿04 AND MESSAGE "T1-TEST, PUMP P1 DEFECTIVE." THE MOTOR PROTECTION SWITCH (MPS) WITHIN STAGE 1 WAS DETERMINED TO BE BAD AND THE CONNECTED WIRING WAS DISCOLORED. IT WAS NOTED THAT THE THERMAL OVERLOAD RELAY HAD TRIPPED. THE BIOMED WAS ADVISED TO REPLACED THE STAGE 1 MPS. A REPLACEMENT MPS WAS NOT AVAILABLE AT THE FACILITY AT THE TIME OF THE EVENT. THE BIOMED REMOVED THE STAGE 2 MPS AND INSTALLED IT INTO STAGE 1 AND RAN THE SYSTEM IN EMERGENCY MODE STAGE 1 IN ORDER TO RETURN THE RO SYSTEM TO SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO REPORTED SMOKE, SPARK, FLAME, OR ARCING. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. 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 THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED THERMAL DAMAGE WAS IDENTIFIED DURING MACHINE REPAIR. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR TROUBLESHOOTING ASSISTANCE AFTER RECEIVING ERROR F¿04¿50¿04 AND MESSAGE "T1-TEST, PUMP P1 DEFECTIVE." THE MOTOR PROTECTION SWITCH (MPS) WITHIN STAGE 1 WAS DETERMINED TO BE BAD AND THE CONNECTED WIRING WAS DISCOLORED. IT WAS NOTED THAT THE THERMAL OVERLOAD RELAY HAD TRIPPED. THE BIOMED WAS ADVISED TO REPLACED THE STAGE 1 MPS. A REPLACEMENT MPS WAS NOT AVAILABLE AT THE FACILITY AT THE TIME OF THE EVENT. THE BIOMED REMOVED THE STAGE 2 MPS AND INSTALLED IT INTO STAGE 1 AND RAN THE SYSTEM IN EMERGENCY MODE STAGE 1 IN ORDER TO RETURN THE RO SYSTEM TO SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO REPORTED SMOKE, SPARK, FLAME, OR ARCING. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. 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.