AQUABPLUS, B2, HF 1000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE L3 CABLE CONNECTION FROM THE MOTOR PROTECTION SWITCH TO THE CONTACTOR WAS BURNED. THE L2 FUSE IN THE EXTERNAL DISCONNECTED WAS FOUND TO BE BLOWN. THE RO SYSTEM ALSO DISPLAYED ERROR F¿04¿51¿04 WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP AND ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING. THERE WAS NO THERMAL DAMAGE IDENTIFIED ON THE MOTOR PROTECTION SWITCH. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO POWER ISSUES REPORTED ON OR AROUND THE REPORTED THE EVENT DATE. THE BURNED CABLE AND BLOWN FUSE (SIZE UNKNOWN) WERE REPLACED TO RESOLVE THE REPORTED ISSUES. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE 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 TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE L3 CABLE CONNECTION FROM THE MOTOR PROTECTION SWITCH TO THE CONTACTOR WAS BURNED. THE L2 FUSE IN THE EXTERNAL DISCONNECTED WAS FOUND TO BE BLOWN. THE RO SYSTEM ALSO DISPLAYED ERROR F¿04¿51¿04 WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP AND ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME OR ARCING. THERE WAS NO THERMAL DAMAGE IDENTIFIED ON THE MOTOR PROTECTION SWITCH. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO POWER ISSUES REPORTED ON OR AROUND THE REPORTED THE EVENT DATE. THE BURNED CABLE AND BLOWN FUSE (SIZE UNKNOWN) WERE REPLACED TO RESOLVE THE REPORTED ISSUES. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. NO PARTS ARE 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 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.