AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. BURNT WIRES WERE FOUND CONNECTED TO THE POWER SWITCH. THE REPORTED ISSUE WAS IDENTIFIED DURING TROUBLESHOOTING AFTER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON DURING MORNING STARTUP. NO VOLTAGE WAS FOUND GOING TO THE RO SYSTEM. TRIP BOXES WERE INSTALLED BETWEEN THE MAIN POWER FUSES AND THE RO. THE BIOMED WAS INSTRUCTED BY FRESENIUS TECHNICAL SERVICES TO REMOVE THE BOXES AS THEY WERE BELIEVED TO BE THE CAUSE OF THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS OBTAINED FROM THE BIOMED DURING FOLLOW-UP. ACCORDING TO THE BIOMED ¿OLD AND DAMAGED WIRES CAUSED EXPOSED WIRES TO ARC WHICH BLEW THE POWER SWITCH AND DAMAGED THE THERMAL OVERLOAD RELAY.¿ THE BIOMED ALSO INDICATED THAT A BURNING SMELL AND SPARK COULD BE OBSERVED. FACILITY SMOKE DETECTORS WERE NOT TRIGGERED. THERE WERE NO ASSOCIATED ALARM CODES RECEIVED. THE THERMAL OVERLAY DID INITIALLY TRIP UNTIL THE WIRES CAUSED THE ARCING. THERE WERE NO BLOWN FUSES FOUND IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE NOR WERE THERE ANY STORMS IN THE AREA AROUND THE TIME OF THE REPORTED ISSUE. THE RO SYSTEM IS PLUGGED INTO ITS OWN CIRCUIT BREAKER. THE 12-GAUGE WIRING, POWER SWITCH, AND THERMAL OVERLOAD RELAY WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF IDENTIFYING THE THERMAL DAMAGE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE MANUFACTURER WAS ABLE TO CONFIRM THE REPORTED ISSUE USING THE INFORMATION PROVIDED BY THE CUSTOMER. THE THERMAL DAMAGE WAS CAUSED BY LOW CONTACT PRESSURE WHICH RESULTED IN CONTACT RESISTANCE AT THE BAD CONTACTED POINT AND A HIGH THERMAL POWER LOSS WAS INDICATED, NOTED AS THE THERMAL DAMAGE. THIS FAILURE PATTERN IS KNOWN AND COVERED BY AN INTERNAL CAPA PROJECT. CORRECTIVE ACTIONS OF THE CAPA WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED. THE AFFECTED DEVICE WAS BUILT BEFORE THE IMPLEMENTATION OF THE CAPA AND WAS STILL EQUIPPED WITH THE OLD DESIGN OF THE CRIMPED CABLE LUG AT TIME OF THE FAILURE ACCORDING TO THE PROVIDED PICTURE. ACCORDING TO THE PROVIDED INFORMATION, THE 12-GAUGE WIRING, POWER SWITCH, AND THERMAL OVERLOAD RELAY WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS THEREFORE RECOMMENDED TO CHECK IF REPLACED WIRING MATCHES THE SPECIFICATIONS OF THE CORRECTIVE ACTIONS AND REPLACE ANY PARTS NECESSARY TO CORRESPOND TO IT.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DAMAGE WAS IDENTIFIED ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. BURNT WIRES WERE FOUND CONNECTED TO THE POWER SWITCH. THE REPORTED ISSUE WAS IDENTIFIED DURING TROUBLESHOOTING AFTER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WOULD NOT POWER ON DURING MORNING STARTUP. NO VOLTAGE WAS FOUND GOING TO THE RO SYSTEM. TRIP BOXES WERE INSTALLED BETWEEN THE MAIN POWER FUSES AND THE RO. THE BIOMED WAS INSTRUCTED BY FRESENIUS TECHNICAL SERVICES TO REMOVE THE BOXES AS THEY WERE BELIEVED TO BE THE CAUSE OF THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS OBTAINED FROM THE BIOMED DURING FOLLOW-UP. ACCORDING TO THE BIOMED ¿OLD AND DAMAGED WIRES CAUSED EXPOSED WIRES TO ARC WHICH BLEW THE POWER SWITCH AND DAMAGED THE THERMAL OVERLOAD RELAY.¿ THE BIOMED ALSO INDICATED THAT A BURNING SMELL AND SPARK COULD BE OBSERVED. FACILITY SMOKE DETECTORS WERE NOT TRIGGERED. THERE WERE NO ASSOCIATED ALARM CODES RECEIVED. THE THERMAL OVERLAY DID INITIALLY TRIP UNTIL THE WIRES CAUSED THE ARCING. THERE WERE NO BLOWN FUSES FOUND IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE NOR WERE THERE ANY STORMS IN THE AREA AROUND THE TIME OF THE REPORTED ISSUE. THE RO SYSTEM IS PLUGGED INTO ITS OWN CIRCUIT BREAKER. THE 12-GAUGE WIRING, POWER SWITCH, AND THERMAL OVERLOAD RELAY WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF IDENTIFYING THE THERMAL DAMAGE. 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.