AQUABPLUS, B2, HF 1500 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 USING THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER. THE MANUFACTURER DETERMINED THE CAUSE OF THE THERMAL DAMAGE TO BE A BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH. THE CONTACT RESISTANCE INCREASED AND THE PUMP CURRENT ALLOWED FOR INCREASED THERMAL ENERGY AT THE CONTACTS POINTS. THE CABLE LUGS CONNECTIONS AT THE MOTOR PROTECTION SWITCH OVERHEATED AND DISCOLORED FROM THE RELEASED THERMAL ENERGY. THE MOTOR PROTECTION SWITCH THEN TRIPPED AND INTERRUPTED DEVICE OPERATION. THIS FAILURE IS A KNOWN ISSUE. CORRECTIVE ACTIONS HAVE BEEN DEFINED. A NEW DESIGN FOR THE MOTOR PROTECTION SWITCH WAS DEVELOPED AND RELEASED, HOWEVER AT THE TIME OF THE REPORTED EVENT THIS DESIGN IMPROVEMENT IS NOT CURRENTLY AVAILABLE FOR THE US MARKET. IT IS RECOMMENDED BY THE MANUFACTURER THAT THE WIRING AND THE MOTOR PROTECTION SWITCH IN BOTH STAGES BE REPLACED IN RESPONSE TO THIS ISSUE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT HEAT DAMAGE WAS FOUND ON THE CONNECTIONS TO THE POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED DESCRIBED THE CONNECTIONS AS DISCOLORED WITH BROWN STAINING. THERE WAS NO REPORTED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. ERROR CODE ¿F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE¿ WAS ENCOUNTERED DURING THE T1 TEST ON 8/17/2024 AND THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2 UNTIL THE SYSTEM COULD BE EVALUATED. THERE WERE NO BLOWN FUSES. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE POWER SWITCH, POWER CABLE, POWER CONTACTOR CABLE, AND THERMAL OVERLOAD RELAY WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO FULL OPERATION FOLLOWING REPAIR. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. NO PARTS ARE AVAILABLE TO BE RETURNED 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.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT HEAT DAMAGE WAS FOUND ON THE CONNECTIONS TO THE POWER SWITCH OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE BIOMED DESCRIBED THE CONNECTIONS AS DISCOLORED WITH BROWN STAINING. THERE WAS NO REPORTED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. ERROR CODE ¿F¿04¿51¿04 FAILURE: T1 TEST, PUMP P1S DEFECTIVE¿ WAS ENCOUNTERED DURING THE T1 TEST ON 8/17/2024 AND THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 2 UNTIL THE SYSTEM COULD BE EVALUATED. THERE WERE NO BLOWN FUSES. THERE WERE NO LOCAL POWER GRID ISSUES OR ELECTRICAL STORMS ON OR AROUND THE REPORTED EVENT DATE. THE POWER SWITCH, POWER CABLE, POWER CONTACTOR CABLE, AND THERMAL OVERLOAD RELAY WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE RO SYSTEM WAS RETURNED TO FULL OPERATION FOLLOWING REPAIR. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.