AQUABPLUS, B2, HF 1500 KIT

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING A MACHINE REPAIR. THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) WAS REPLACING A MEMBRANE WHEN EVIDENCE OF ARCING WAS NOTED ON THE MOTOR PROTECTION SWITCH UPON REMOVING THE STAGE 1 HOOD. THERE WAS NO OBSERVED BURNING, SMOKE, SPARK, OR FLAME. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON THE REPORTED EVENT. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED REPLACED THE MPS AND CONNECTED WIRING TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. NO SAMPLE WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE MANUFACTURER CONFIRMED THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION AND SAMPLE PHOTOGRAPHS. THE COMPLAINT INVESTIGATION DETERMINED THAT THE LIKELY CAUSE OF THE THERMAL DAMAGE WAS A LOOSE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. IN SUCH AN INSTANCE THE PUMP WILL RUN ONLY WITH TWO LINE CONDUCTORS, RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE CABLE LUGS AT THE MOTOR PROTECTION SWITCH CAN GET OVERHEATED AND DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT. THIS IS A KNOWN FAILURE. CORRECTIVE ACTIONS HAVE BEEN DEFINED AND IMPLEMENTED FOR THIS KNOWN FAILURE. THE WIRING WAS REDESIGNED AND RELEASED. IN THIS INSTANCE THE SWITCH AND CONNECTED WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE MOTOR PROTECTION SWITCH AND BLACK CONNECTION WIRES AGAINST THE IMPROVED DESIGN IN STAGE 1 AND STAGE 2.

Description of Event or Problem

A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING A MACHINE REPAIR. THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) WAS REPLACING A MEMBRANE WHEN EVIDENCE OF ARCING WAS NOTED ON THE MOTOR PROTECTION SWITCH UPON REMOVING THE STAGE 1 HOOD. THERE WAS NO OBSERVED BURNING, SMOKE, SPARK, OR FLAME. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY. THE THERMAL OVERLOAD RELAY DID NOT TRIP. THERE WERE NO LOCAL POWER GRID ISSUES ON THE REPORTED EVENT. THE RO SYSTEM IS PLUGGED INTO ITS OWN BREAKER. THE BIOMED REPLACED THE MPS AND CONNECTED WIRING TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO SERVICE. NO SAMPLE WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.