AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE WAS CONFIRMED BASED ON THE INTAKE INFORMATION PROVIDED BY THE CUSTOMER. THE REPORTED THERMAL DAMAGE WAS FOUND ON THE WIRING OF THE STAGE 1 MOTOR PROTECTION SWITCH DURING PREVENTIVE MAINTENANCE. THE REPORTED EVENT CAN BE ATTRIBUTED TO POOR ELECTRICAL CONTACT BETWEEN THE CABLE LUGS AND THEIR CONTACT PINS AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT LED TO AN INCREASE IN 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. THIS FAILURE PATTERN IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND ARE IN THE PROCESS OF IMPLEMENTATION. A NEW DESIGN OF THE MOTOR PROTECTION SWITCH AND ITS WIRING IS DEVELOPED, BUT CURRENTLY NOT RELEASED FOR THE US MARKET. ACCORDING TO THE PROVIDED INFORMATION, THE ISSUE WAS SOLVED ONSITE BY REPLACING THE WIRING AND THE MOTOR PROTECTION SWITCH.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SIGNS OF HEAT DAMAGE WERE DISCOVERED BEHIND THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DURING PREVENTATIVE MAINTENANCE (PM). ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THERE WERE NO ALARMS OR ERROR MESSAGES RECEIVED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES OR TRIPPED RELAYS FOUND. ADDITIONALLY, THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE MPS AND CABLE CONNECTIONS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. A REPLACEMENT POWER CABLE WAS ALSO ORDERED AS A PRECAUTION. THE RO SYSTEM WAS RETURNED TO SERVICE AFTER PM WAS COMPLETED. THE SAMPLES WERE DISPOSED FOLLOWING REPAIR AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION.

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 SIGNS OF HEAT DAMAGE WERE DISCOVERED BEHIND THE STAGE 1 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM DURING PREVENTATIVE MAINTENANCE (PM). ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED. THERE WERE NO ALARMS OR ERROR MESSAGES RECEIVED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES OR TRIPPED RELAYS FOUND. ADDITIONALLY, THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS IN THE AREA ON OR AROUND THE REPORTED EVENT DATE. THE MPS AND CABLE CONNECTIONS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. A REPLACEMENT POWER CABLE WAS ALSO ORDERED AS A PRECAUTION. THE RO SYSTEM WAS RETURNED TO SERVICE AFTER PM WAS COMPLETED. THE SAMPLES WERE DISPOSED FOLLOWING REPAIR AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION.