AQUABPLUS, B2, HF 2000 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR F-04-51-04 AND THE MESSAGE "T1 TEST, PUMP P1S DEFECTIVE" WAS RECEIVED DURING THE T1 TEST. UPON EVALUATION THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN STAGE 2 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. L1 AND THE MAIN POWER CABLE APPEARED DISCOLORED AS WELL AS THE TOP THREE WIRES CONNECTING FROM THE MOTOR PROTECTION SWITCH (MPS) TO THE POWER SWITCH. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES. 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. PER THE RECOMMENDATION OF TECHNICAL SERVICES, THE CONTACTOR, MPS, AND POWER SWITCH, AND CONNECTED CABLES WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. THE SAMPLES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER WITH THE INTAKE INFORMATION PROVIDED BY THE CUSTOMER. 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. THE REDESIGN IS CURRENTLY NOT AVAILABLE FOR THE US MARKET. ACCORDING THE COMPLAINT INTAKE INFORMATION THE ISSUE WAS SOLVED BY REPLACING THE CONTACTOR, MOTOR PROTECTION SWITCH AND WIRING.

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 THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR F-04-51-04 AND THE MESSAGE "T1 TEST, PUMP P1S DEFECTIVE" WAS RECEIVED DURING THE T1 TEST. UPON EVALUATION THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN STAGE 2 OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. L1 AND THE MAIN POWER CABLE APPEARED DISCOLORED AS WELL AS THE TOP THREE WIRES CONNECTING FROM THE MOTOR PROTECTION SWITCH (MPS) TO THE POWER SWITCH. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES. 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. PER THE RECOMMENDATION OF TECHNICAL SERVICES, THE CONTACTOR, MPS, AND POWER SWITCH, AND CONNECTED CABLES WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. THE SAMPLES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.