AQUABPLUS, B2, HF 1000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THE WIRES WITHIN STAGE 2 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE MELTED. THE BIOMED DISCOVERED THE THERMAL DECOMPOSITION DURING MACHINE REPAIR WHEN STAGE 2 STOPPED RUNNING. THE TOP COVER WAS REMOVED AND THE THERMAL OVERLOAD RELAY WAS RESET BUT ONLY RAN FOR A COUPLE OF MINUTES BEFORE TURNING OFF AGAIN. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING UPON DISCOVERING THE IDENTIFIED THERMAL DECOMPOSITION. A FRESENIUS WATER SYSTEM SERVICE SPECIALIST CAME ONSITE TO EVALUATE THE RO SYSTEM FOR THIS ISSUE AS WELL AS A V10 LEAKAGE AND TO REPLACE THE MEMBRANE AT THE CUSTOMER'S REQUEST. THE WATER SYSTEM SERVICE SPECIALIST REPLACED THE THERMAL OVERLOAD RELAY, THE POWER CONTACTOR, THE CABLES FROM THE MOTOR PROTECTION SWITCH TO THE CONTACTOR, THE MOTOR PROTECTION SWITCH, AND THE MAINS POWER CABLE. THE MEMBRANES WITHIN STAGE 1 APPEARED STAINED BY AN "IRON LOOKING SUBSTANCE." THE MEMBRANES WERE REPLACED AND THE MEMBRANE HOUSINGS WERE SCRUBBED AND FLUSHED. THE V10 WAS ALSO REPLACED TO ADDRESS THE V10 LEAKAGE ISSUE. THE RO SYSTEM WAS DISINFECTED AND RELEASED TO THE CUSTOMER. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER AND USED BY THE MANUFACTURER TO CONFIRM THE REPORTED EVENT. THIS FAILURE CAN BE ATTRIBUTED TO BAD ELECTRICAL CONTACTING BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH OVERHEATED AND DISCOLORED FROM THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. DUE TO THE BAD ELECTRICAL CONTACT, THE THERMAL OVERLOAD SWITCH BECAME UNBALANCED AND TRIPPED AS INTENDED. THIS FAILURE IS A KNOWN ISSUE. THE DESIGN OF THE ELECTRICAL CONTACT OF THIS APPLICATION WAS DETERMINED TO BE INADEQUATE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND ARE UNDER IMPLEMENTATION. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING HAS BEEN DEVELOPED BUT IS CURRENTLY NOT RELEASED FOR THE US MARKET. THIS FAILURE WAS RESOLVED BY REPLACING THE WIRING, THE MOTOR PROTECTION SWITCH, THE CONTACTOR, THE POWER CORD AND THE THERMAL OVERLOAD SWITCH IN 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 THAT THE WIRES WITHIN STAGE 2 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE MELTED. THE BIOMED DISCOVERED THE THERMAL DECOMPOSITION DURING MACHINE REPAIR WHEN STAGE 2 STOPPED RUNNING. THE TOP COVER WAS REMOVED AND THE THERMAL OVERLOAD RELAY WAS RESET BUT ONLY RAN FOR A COUPLE OF MINUTES BEFORE TURNING OFF AGAIN. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING UPON DISCOVERING THE IDENTIFIED THERMAL DECOMPOSITION. A FRESENIUS WATER SYSTEM SERVICE SPECIALIST CAME ONSITE TO EVALUATE THE RO SYSTEM FOR THIS ISSUE AS WELL AS A V10 LEAKAGE AND TO REPLACE THE MEMBRANE AT THE CUSTOMER'S REQUEST. THE WATER SYSTEM SERVICE SPECIALIST REPLACED THE THERMAL OVERLOAD RELAY, THE POWER CONTACTOR, THE CABLES FROM THE MOTOR PROTECTION SWITCH TO THE CONTACTOR, THE MOTOR PROTECTION SWITCH, AND THE MAINS POWER CABLE. THE MEMBRANES WITHIN STAGE 1 APPEARED STAINED BY AN "IRON LOOKING SUBSTANCE." THE MEMBRANES WERE REPLACED AND THE MEMBRANE HOUSINGS WERE SCRUBBED AND FLUSHED. THE V10 WAS ALSO REPLACED TO ADDRESS THE V10 LEAKAGE ISSUE. THE RO SYSTEM WAS DISINFECTED AND RELEASED TO THE CUSTOMER. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT SAMPLES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.