AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE LEGS CONNECTED TO THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR ASSISTANCE WHEN THE MPS WAS TRIPPING. THE FUSES IN THE DISCONNECT WERE CHECKED AND NO ISSUES WERE NOTED. UPON INSPECTION OF THE MPS, TWO LEGS WERE NOTED TO BE LOOSE ON THE MAIN POWER CABLE AND ALL 3 LEGS APPEARED DISCOLORED AND BURNT. THE BIOMED WAS ADVISED TO REPLACE THE MPS AND THE MAIN POWER CABLE. THE T1 TEST PASSED AFTER THE POWER CABLE WAS RESEATED TO THE MOTOR PROTECTION SWITCH. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED ALSO CONFIRMED RECEIVING ERROR F¿04¿50¿04 WITH MESSAGE "FAILURE: T1 TEST, PUMP P1 DEFECTIVE." THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY. THERE WERE NO POWER ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. UPON DISCOVERING THE THERMAL DAMAGE, THE RO SYSTEM WAS PLACED IN EMERGENCY MODE STAGE 2 UNTIL THE AFFECTED PARTS COULD BE REPLACED. THE MPS AND CONNECTED WIRING WERE LATER REPLACED TO RESOLVE THE REPORTED ISSUE. 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.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE LEGS CONNECTED TO THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED INITIALLY CONTACTED FRESENIUS FOR ASSISTANCE WHEN THE MPS WAS TRIPPING. THE FUSES IN THE DISCONNECT WERE CHECKED AND NO ISSUES WERE NOTED. UPON INSPECTION OF THE MPS, TWO LEGS WERE NOTED TO BE LOOSE ON THE MAIN POWER CABLE AND ALL 3 LEGS APPEARED DISCOLORED AND BURNT. THE BIOMED WAS ADVISED TO REPLACE THE MPS AND THE MAIN POWER CABLE. THE T1 TEST PASSED AFTER THE POWER CABLE WAS RESEATED TO THE MOTOR PROTECTION SWITCH. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED ALSO CONFIRMED RECEIVING ERROR F¿04¿50¿04 WITH MESSAGE "FAILURE: T1 TEST, PUMP P1 DEFECTIVE." THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY. THERE WERE NO POWER ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. UPON DISCOVERING THE THERMAL DAMAGE, THE RO SYSTEM WAS PLACED IN EMERGENCY MODE STAGE 2 UNTIL THE AFFECTED PARTS COULD BE REPLACED. THE MPS AND CONNECTED WIRING WERE LATER REPLACED TO RESOLVE THE REPORTED ISSUE. 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 SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER 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. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED FOR THIS KNOWN FAILURE. THE WIRING WAS REDESIGNED AND RELEASED. THE DEVICE WAS BUILT BEFORE THE IMPROVEMENT OF THE DESIGN. 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.