AQUABPLUS, B2, HF 1000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER BASED ON THE INFORMATION PROVIDED UPON INTAKE AND THE ADDITIONAL FEEDBACK THAT WAS RECEIVED DURING FOLLOW-UP. THE REPORTED EVENT CAN BE ATTRIBUTED TO THE FAILURE PATTERN BAD ELECTRICAL CONTACTING BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. THE THERMAL DAMAGE WAS MOST LIKELY CAUSED BY A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASES LEADING TO INCREASED THERMAL ENERGY AT THE CONTACTS POINTS THAT CAN OVERHEAT AND DAMAGE THE CABLE LUGS AT THE MOTOR PROTECTION. THIS FAILURE PATTERN IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING IS DEVELOPED, BUT CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE INTAKE INFORMATION, THE ISSUE WAS SOLVED ON SITE BY REPLACING THE MOTOR PROTECTION SWITCH AND THE WIRING IN STAGE 1 AND THE MACHINE HAS BEEN RETURNED TO SERVICE. THE DEVICE HISTORY RECORD RELATED DOCUMENTATION HAS BEEN REVIEWED. THE DEVICE HAS BEEN FOUND TO BE CONFORMING TO THE SPECIFICATIONS AND HAS BEEN RELEASED WITHOUT ANY DISCREPANCIES.

Description of Event or Problem

A SENIOR WATER SYSTEM EDUCATOR REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE MOTOR PROTECTION SWITCH AND CONNECTORS WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM HAD MELTED. THE REPORTED EVENT WAS CONFIRMED DURING FOLLOW-UP AND ADDITIONAL INFORMATION WAS PROVIDED. THE EDUCATOR WAS TEACHING A CLASS REGARDING MAINTENANCE WHEN THE REPORTED ISSUE WAS DISCOVERED. THE THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) AND WIRE CONNECTIONS UPON LIFTING THE STAGE 1 HOOD. THE EDUCATOR DESCRIBED THE PARTS AS MELTED. THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE EDUCATOR CONFIRMED THAT THE RO SYSTEM WAS POWERED OFF WHEN THE REPORTED ISSUE WAS IDENTIFIED. NO ALARMS OR ERRORS WERE RECEIVED. THE EDUCATOR CONFIRMED THAT THE THERMAL OVERLOAD RELAY DID NOT TRIP. NO BLOWN FUSES WERE IDENTIFIED. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO POWER ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE EDUCATOR CONFIRMED THAT THE MPS AND WIRES LEADING TO THE CONTACTOR WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE THE FOLLOWING DAY. THE PARTS WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Description of Event or Problem

A SENIOR WATER SYSTEM EDUCATOR REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE MOTOR PROTECTION SWITCH AND CONNECTORS WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM HAD MELTED. THE REPORTED EVENT WAS CONFIRMED DURING FOLLOW-UP AND ADDITIONAL INFORMATION WAS PROVIDED. THE EDUCATOR WAS TEACHING A CLASS REGARDING MAINTENANCE WHEN THE REPORTED ISSUE WAS DISCOVERED. THE THERMAL DAMAGE WAS IDENTIFIED ON THE MOTOR PROTECTION SWITCH (MPS) AND WIRE CONNECTIONS UPON LIFTING THE STAGE 1 HOOD. THE EDUCATOR DESCRIBED THE PARTS AS MELTED. THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE EDUCATOR CONFIRMED THAT THE RO SYSTEM WAS POWERED OFF WHEN THE REPORTED ISSUE WAS IDENTIFIED. NO ALARMS OR ERRORS WERE RECEIVED. THE EDUCATOR CONFIRMED THAT THE THERMAL OVERLOAD RELAY DID NOT TRIP. NO BLOWN FUSES WERE IDENTIFIED. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THERE WERE NO POWER ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE EDUCATOR CONFIRMED THAT THE MPS AND WIRES LEADING TO THE CONTACTOR WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE THE FOLLOWING DAY. THE PARTS WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE.

Additional Manufacturer Narrative

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