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 WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. BURN MARKS WERE VISUALLY OBSERVED ON THE WIRING OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS). THE BIOMED INDICATED THAT THE MPS TRIPPED DURING THE T1 TEST IN STARTUP AND DISINFECT MODES. ERROR CODE F¿04¿51¿04 WAS RECEIVED ALONG WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE BIOMED SECURED THE WIRING FOR A BETTER CONNECTION AND RESET THE SWITCH WHICH RESOLVED THE REPORTED ERROR MESSAGE. THE BIOMED REQUESTED THE PART NUMBER FOR A REPLACEMENT SWITCH. PART NUMBER F000005352 WAS PROVIDED TO THE BIOMED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE BIOMED CONFIRMED THAT THERMAL DAMAGE WAS IDENTIFIED ON THE WIRES THAT CONNECT TO THE SAFETY SHUT OFF SWITCH ON STAGE 2 OF THE RO SYSTEM. THE BIOMED BELIEVED THE DAMAGE MOST LIKELY OCCURRED OVER A PERIOD OF TIME. THE RO FAILED TO PASS THE T1 TEST IN BOTH DISINFECT AND STARTUP MODES UPON INITIATING MONTHLY DISINFECTION. THE SUSPECTED CAUSE OF THE FAILURE IS LOOSE FITTING WIRES FROM VIBRATION OVER TIME, THAT MAY HAVE CAUSED SMALL ARCS THAT CAN BLACKEN WIRES AND CAUSE DAMAGE TO THE SAFETY CUTOFF SWITCH. THE BIOMED CONFIRMED THAT THE ONLY VISIBLE DAMAGE WAS THE WIRES THAT CONNECT TO THE STAGE 2 SAFETY SWITCH. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED DID NOT BELIEVE THE THERMAL OVERLOAD RELAY TRIPPED. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE EVENT DATE, NOR WERE ANY STORMS OCCURRING IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE MACHINE IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED STATED THAT THE SWITCH AND WIRE HARNESSES HAVE BEEN REPLACED WITH UPGRADED PARTS TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. NO PHOTOGRAPHS, FILES, OR SAMPLES WERE REPORTED TO BE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUAL 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. 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.

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. BURN MARKS WERE VISUALLY OBSERVED ON THE WIRING OF THE STAGE 2 MOTOR PROTECTION SWITCH (MPS). THE BIOMED INDICATED THAT THE MPS TRIPPED DURING THE T1 TEST IN STARTUP AND DISINFECT MODES. ERROR CODE F¿04¿51¿04 WAS RECEIVED ALONG WITH THE MESSAGE "FAILURE: T1 TEST, PUMP P1S DEFECTIVE." THE BIOMED SECURED THE WIRING FOR A BETTER CONNECTION AND RESET THE SWITCH WHICH RESOLVED THE REPORTED ERROR MESSAGE. THE BIOMED REQUESTED THE PART NUMBER FOR A REPLACEMENT SWITCH. PART NUMBER F000005352 WAS PROVIDED TO THE BIOMED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THE BIOMED CONFIRMED THAT THERMAL DAMAGE WAS IDENTIFIED ON THE WIRES THAT CONNECT TO THE SAFETY SHUT OFF SWITCH ON STAGE 2 OF THE RO SYSTEM. THE BIOMED BELIEVED THE DAMAGE MOST LIKELY OCCURRED OVER A PERIOD OF TIME. THE RO FAILED TO PASS THE T1 TEST IN BOTH DISINFECT AND STARTUP MODES UPON INITIATING MONTHLY DISINFECTION. THE SUSPECTED CAUSE OF THE FAILURE IS LOOSE FITTING WIRES FROM VIBRATION OVER TIME, THAT MAY HAVE CAUSED SMALL ARCS THAT CAN BLACKEN WIRES AND CAUSE DAMAGE TO THE SAFETY CUTOFF SWITCH. THE BIOMED CONFIRMED THAT THE ONLY VISIBLE DAMAGE WAS THE WIRES THAT CONNECT TO THE STAGE 2 SAFETY SWITCH. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE BIOMED DID NOT BELIEVE THE THERMAL OVERLOAD RELAY TRIPPED. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE EVENT DATE, NOR WERE ANY STORMS OCCURRING IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. IT WAS CONFIRMED THE MACHINE IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED STATED THAT THE SWITCH AND WIRE HARNESSES HAVE BEEN REPLACED WITH UPGRADED PARTS TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. NO PHOTOGRAPHS, FILES, OR SAMPLES WERE REPORTED TO BE AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF THE REPORTED ISSUE.