AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP WITH THE BIOMED AND ADDITIONAL INFORMATION WAS PROVIDED. THE BIOMED STATED THAT UPON STARTING THE RO SYSTEM AT THE BEGINNING OF THE DAY THAT THE FRONT DISPLAY WOULD BLINK ON MOMENTARILY THEN BLINK OFF. NO ERRORS OR ALARMS WERE DISPLAYED. UPON TROUBLESHOOTING, DISCOLORATION WAS NOTED TO THE SIX WIRES CONNECTED TO THE STAGE 1 MOTOR PROTECTION SWITCH. THE THERMAL OVERLOAD RELAYS ALSO TRIPPED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED. THERE WERE NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS SECURED PLUGGED INTO ITS OWN BREAKER. THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE THERMAL OVERLOAD RELAYS WERE ALSO RESET. THE RO SYSTEM WAS RETURNED TO FULL OPERATION. THE SAMPLES WERE DISCARDED AND ARE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED ISSUE BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THAT THE THERMAL DAMAGE OCCURRED DUE TO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS AT AS THE RESULT OF POOR ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE HIGH CURRENTS RESULTED IN THERMAL DAMAGE TO THE WIRES AND CABLE LUGS. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. THE CRIMPED CABLE LUG HAS BEEN RE-DESIGNED. THE MACHINE WAS MANUFACTURED PRIOR TO RELEASE THE RE-DESIGNED CRIMPED CABLE LUG. A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. IN THIS CASE, THE SWITCH AND WIRING HAVE BEEN REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS ALSO RECOMMENDED TO REPLACE THE STAGE 2 SWITCH AND WIRING WITH THE NEW DESIGN.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP WITH THE BIOMED AND ADDITIONAL INFORMATION WAS PROVIDED. THE BIOMED STATED THAT UPON STARTING THE RO SYSTEM AT THE BEGINNING OF THE DAY THAT THE FRONT DISPLAY WOULD BLINK ON MOMENTARILY THEN BLINK OFF. NO ERRORS OR ALARMS WERE DISPLAYED. UPON TROUBLESHOOTING, DISCOLORATION WAS NOTED TO THE SIX WIRES CONNECTED TO THE STAGE 1 MOTOR PROTECTION SWITCH. THE THERMAL OVERLOAD RELAYS ALSO TRIPPED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED. THERE WERE NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS SECURED PLUGGED INTO ITS OWN BREAKER. THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE THERMAL OVERLOAD RELAYS WERE ALSO RESET. THE RO SYSTEM WAS RETURNED TO FULL OPERATION. THE SAMPLES WERE DISCARDED AND ARE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.