AQUABPLUS, B2, HF 1000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SERVICES AFTER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODES ¿F¿02¿50¿05 FAILURE: RUN-DRY PROTECTION¿ AND ¿F¿04¿51¿03 FAILURE: T1 TEST, P-S SWITCH DEFECTIVE.¿ IT WAS DISCOVERED THAT THE P-S SENSOR WAS INCORRECTLY CONNECTED. CORRECTING THE WIRE CONNECTIONS RESOLVED BOTH ERRORS. DURING TROUBLESHOOTING THERMAL DECOMPOSITION WAS ALSO IDENTIFIED WITHIN STAGE 1. THE CONNECTIONS AT THE POWER SWITCH AND WIRING WERE DESCRIBED AS DISCOLORED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE POWER SUPPLY UNIT AND WIRING WERE REPLACED TO RESOLVE THE REPORTED THERMAL DECOMPOSITION. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PHOTOGRAPHS OR SAMPLES WERE PROVIDED FOR REVIEW BY THE MANUFACTURER. HOWEVER THE REPORTED EVENT CAN BE CONFIRMED BY MEANS OF THE COMPLAINT INTAKE INFORMATION. THE THERMAL DAMAGE OCCURRED DUE A BAD ELECTRICAL CONNECTION THAT RESULTED IN HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS. AS HIGHER CURRENTS, THE CONCERNED COMPONENTS ARE EXPOSED TO HIGHER TEMPERATURES RESPECTIVELY, RESULTING IN THE FOUND THERMAL DAMAGE. THE REPORTED FAILURE PATTERN IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. A NEW CRIMP CONNECTION WAS REDESIGNED. THIS DESIGN WAS RELEASED AFTER THE MANUFACTURE FOR THIS DEVICE. THE POWER SUPPLY UNIT AND WIRING WERE REPLACED TO RESOLVE 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) CONTACTED FRESENIUS TECHNICAL SERVICES AFTER THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODES ¿F¿02¿50¿05 FAILURE: RUN-DRY PROTECTION¿ AND ¿F¿04¿51¿03 FAILURE: T1 TEST, P-S SWITCH DEFECTIVE.¿ IT WAS DISCOVERED THAT THE P-S SENSOR WAS INCORRECTLY CONNECTED. CORRECTING THE WIRE CONNECTIONS RESOLVED BOTH ERRORS. DURING TROUBLESHOOTING THERMAL DECOMPOSITION WAS ALSO IDENTIFIED WITHIN STAGE 1. THE CONNECTIONS AT THE POWER SWITCH AND WIRING WERE DESCRIBED AS DISCOLORED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE EXTERNAL SERVICE DISCONNECT. THE HEATER RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE POWER SUPPLY UNIT AND WIRING WERE REPLACED TO RESOLVE THE REPORTED THERMAL DECOMPOSITION. THE RO SYSTEM WAS RETURNED TO SERVICE. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.