AQUABPLUS 2500 B2 2000

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 USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM ALARMED WITH ERROR CODE W¿02¿51¿03 WARNING: CONCENTRATE PRESSURE TOO LOW. THE STAGE 2 PSI WAS 3.6 AND THE PUMP WAS NOT RUNNING. IN A SUBSEQUENT CALL THE BIOMED REPORTED THAT THE MOTOR PROTECTION SWITCH (MPS) WAS REPLACED BUT AFTER A SHORT DURATION THE RO SYSTEM ALARMED DURING THE T1 TEST WITH ERROR CODE F-04-51-04 SUPPLY FAILURE: P1 TEST PUMP DEFECTIVE. THE BIOMED WAS ADVISED TO VERIFY THAT THE STAGE 2 CONTACTOR IS ATTACHED TO THE MOTOR PROTECTION REPLAY. THE RELAY WAS RESET WHICH DID NOT SECURE INTO PLACE. THE BIOMED WAS ADVISED TO REENABLE POWER BEFORE GOING TO SERVICE MODE TO ACCESS THE SERVICE ROUTINES. THE BIOMED PERFORMED THE DISCARD PERMEATE OPTION AND WAS ADVISED TO MONITOR STAGE 2 WHEN A SMALL SPARK WAS OBSERVED. THE BIOMED WAS INSTRUCTED TO VERIFY THE WIRE CONNECTIONS/CONDITION AT THE SPARK'S LOCATION AFTER DE-ENERGIZING THE DEVICE. THE BIOMED NOTED SOME FRAYING ON THE WIRE. THE DEVICE ALSO TRIPPED ON THE NEXT ATTEMPT. DISCOLORATION WAS ALSO NOTED ON THE MOTOR PROTECTION SWITCH WIRE. THE BIOMED WAS INSTRUCTED TO VERIFY THE STAGE 2 MOTOR PROTECTION RELAY. THE DEVICE SPARKED WHEN STAGE 2 WAS POWERED ON. THE DEVICE WAS INERT. UPON VERIFICATION, THE BIOMED FOUND THAT THE WIRES HAD BECOME DISLODGED FROM THE HOUSING. THE BIOMED WAS PROVIDED WITH PART NUMBERS FOR THE MPS, MAIN POWER SWITCH, AND STAGE 2 HOOD FOR RETROFIT ASSEMBLY. THE BIOMED WAS ADVISED TO ORDER AND REPLACE THE PARTS. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED. THERE WAS NO REPORTED HARM TO ANY PATIENTS AS A RESULT OF THIS MALFUNCTION. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.