AQUABPLUS, B2, HF 2500 KIT

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

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ENCOUNTERED AN H2 DEFECTIVE MESSAGE DURING HEAT DISINFECTION. ERROR CODE "W¿04¿52¿02 WARNING: T1 TEST, HEATER H2 DEFECTIVE" WAS RECEIVED. TROUBLESHOOTING REVEALED A TRIPPED F3 SWITCH AS WELL AS BURN DAMAGE TO THE WIRES CONNECTED FROM Q2 TO F3. THE WIRES WERE DESCRIBED AS CHARRED. THERE WAS NO REPORTED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE F3 LINE SAFETY SWITCH WAS RESET. UPON FOLLOW-UP THE BIOMED STATED THAT Q2 WAS REPLACED TO RESOLVE THE THERMAL DAMAGE. HEAT DISINFECTION WAS COMPLETED AND THERE HAS BEEN NO REOCCURRENCE OF THE REPORTED ISSUE FOLLOWING THE Q2 REPLACEMENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE INDICATED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER, THE REPORTED EVENT CAN BE CONFIRMED FROM THE PROVIDED INTAKE INFORMATION AND PHOTOGRAPHS. THE REPORTED EVENT WAS MOST LIKELY CAUSED FROM BAD ELECTRICAL CONTACTING AT CONTACTOR Q2 AND CIRCUIT BREAKER F3 IN THE ELECTRICAL CABINET OF THE AQUABPLUS HF .DUE TO THE BAD ELECTRICAL CONTACTING, THE THERMAL ENERGY AND HEAT EMISSION WERE INCREASED, RESULTING IN THE FOUND THERMAL DAMAGE AT CONTACTOR Q2 AND CIRCUIT BREAKER F3 IN THE ELECTRICAL CABINET OF THE AQUABPLUS HF. THE BAD ELECTRICAL CONTACTS WERE MOST LIKELY CAUSED BY LOOSENED SCREW CONNECTIONS DURING SHIPMENT. THIS ISSUE IS A KNOWN FAILURE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE SERVICE MANUAL HAS BEEN UPDATED WITH INFORMATION ABOUT THE REQUIRED TIGHTENING TORQUES FOR THE SCREW TERMINAL CONNECTIONS DURING OPERATIONAL QUALIFICATION. ACCORDING THE AVAILABLE INFORMATION, CONTACTOR Q2 WAS REPLACED AND CIRCUIT BREAKER F3 WAS RESET TO RESOLVE THE ISSUE. IT IS RECOMMENDED TO CHECK THE TIGHTENING TORQUES OF ALL SCREW TERMINAL CONNECTIONS IN THE AQUABPLUS, THE AQUABPLUS B2 AND THE AQUABPLUS HF.

Description of Event or Problem

THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ENCOUNTERED AN H2 DEFECTIVE MESSAGE DURING HEAT DISINFECTION. ERROR CODE "W¿04¿52¿02 WARNING: T1 TEST, HEATER H2 DEFECTIVE" WAS RECEIVED. TROUBLESHOOTING REVEALED A TRIPPED F3 SWITCH AS WELL AS BURN DAMAGE TO THE WIRES CONNECTED FROM Q2 TO F3. THE WIRES WERE DESCRIBED AS CHARRED. THERE WAS NO REPORTED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE F3 LINE SAFETY SWITCH WAS RESET. UPON FOLLOW-UP THE BIOMED STATED THAT Q2 WAS REPLACED TO RESOLVE THE THERMAL DAMAGE. HEAT DISINFECTION WAS COMPLETED AND THERE HAS BEEN NO REOCCURRENCE OF THE REPORTED ISSUE FOLLOWING THE Q2 REPLACEMENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE INDICATED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.