AQUABPLUS, B2, HF 2500 KIT

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THE MOTOR PROTECTION SWITCH AND CONNECTED WIRES ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE BURNED. THE DAMAGE OCCURRED IN STAGE 1 AND THE BURNT WIRES WERE LOCATED BEHIND THE SWITCH. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE USER FACILITY BIOMED. THE BIOMED STATED THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS EVALUATED AFTER THE PUMP IN STAGE 2 TRIPPED. NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS WERE REPORTED TO THE BIOMED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS SECURED PLUGGED INTO ITS OWN BREAKER. THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO FULL OPERATION. THE SAMPLES WERE DISCARDED AND ARE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS OF THE REPORTED THERMAL DAMAGE WERE AVAILABLE. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER WITH THE INFORMATION THAT WAS PROVIDED BY THE CUSTOMER. THE LIKELY CAUSE OF THE REPORTED ISSUE IS POOR ELECTRICAL CONTACTS, WHICH LEADS TO INCREASED RESISTANCE AND THERMAL ENERGY THAT OVERHEATS AND DISCOLORS THE AFFECTED PARTS. THESE IS KNOWN FAILURES. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE PARTS WERE REDESIGNED AND RELEASED. THE DEVICE WAS BUILT PRIOR TO THE RELEASE OF THE DESIGN IMPROVEMENTS. REVIEW OF THE DEVICE HISTORY RECORD IS NOT REQUIRED.

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 THE MOTOR PROTECTION SWITCH AND CONNECTED WIRES ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE BURNED. THE DAMAGE OCCURRED IN STAGE 1 AND THE BURNT WIRES WERE LOCATED BEHIND THE SWITCH. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE USER FACILITY BIOMED. THE BIOMED STATED THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WAS EVALUATED AFTER THE PUMP IN STAGE 2 TRIPPED. NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS WERE REPORTED TO THE BIOMED. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WERE NO BLOWN FUSES IDENTIFIED. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES NOR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE RO SYSTEM IS SECURED PLUGGED INTO ITS OWN BREAKER. THE MOTOR PROTECTION SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO FULL OPERATION. THE SAMPLES WERE DISCARDED AND ARE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOGRAPHS OF THE REPORTED THERMAL DAMAGE WERE AVAILABLE. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION.