AQUABPLUS, B2, HF 1500 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

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM TRIPPED. THE ERROR F-04-51-03: FAILURE T1 TEST P-ES SWITCH DEFECTIVE MESSAGE WAS RECEIVED DURING THE T1 TEST. THE STAGE 2 MPS WAS REPLACED AND THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 1 TO RUN PATIENT TREATMENTS UNTIL THE SYSTEM COULD BE TESTED. THE BIOMED STATED DURING TESTING THAT STAGE 2 WOULD NOT POWER ON. WHEN ATTEMPTING TO POWER ON STAGE 2, THE MPS TRIPS (THE GREEN BUTTON POPS OUT) AND THE UNIT POWERS DOWN IMMEDIATELY. THE BIOMED ALSO REPORTED THAT SPARKING WAS OBSERVED FROM THE ¿L2¿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

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. HOWEVER THE REPORTED ISSUE WAS CONFIRMED BY THE MANUFACTURER BASED ON THE INFORMATION PROVIDED UPON INTAKE. THE COMPLAINT INTAKE INFORMATION IS SUFFICIENT FOR DETERMINING THE FAILURE CAUSES. THE FAILURE CAUSE FOR THE POWER OUTAGE CAN BE ATTRIBUTED TO AN ISSUE WITH THE LOCAL MAINS POWER SUPPLY. THERMAL DAMAGE ON CABLE LUGS AT THE MOTOR PROTECTION SWITCH STAGE 2 IS DUE TO BAD ELECTRICAL CONTACTING. THE THERMAL DAMAGE ON THE CABLE LUGS ATTACHED TO THE MOTOR PROTECTION SWITCH OCCURRED DUE TO HIGH CONTACT RESISTANCE AND THERMAL POWER LOSS AT THE BAD CONNECTION. AS HIGHER CURRENTS WILL OCCUR IN SUCH A SCENARIO, THE WIRES AND CABLE LUGS ARE EXPOSED TO HIGHER TEMPERATURES RESPECTIVELY, RESULTING IN THE IDENTIFIED THERMAL DAMAGE. THE POWER FLUCTUATIONS ARE A CONTRIBUTING FACTOR, CAUSING HIGHER CURRENTS AND IN CONSEQUENCE HIGHER THERMAL ENERGIES. THIS FAILURE PATTERN IS A KNOWN ISSUE. CORRECTIVE ACTIONS WERE DEFINED AND IMPLEMENTED. THE DESIGN OF THE CRIMPED CABLE LUG WAS CHANGED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT REQUIRED IN THIS CASE. THE MOTOR PROTECTION SWITCH STAGE 2 AND CONTACTOR AT STAGE 2 WERE REPLACED TO SOLVE THE ISSUE.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE STAGE 2 MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM TRIPPED. THE ERROR F-04-51-03: FAILURE T1 TEST P-ES SWITCH DEFECTIVE MESSAGE WAS RECEIVED DURING THE T1 TEST. THE STAGE 2 MPS WAS REPLACED AND THE RO SYSTEM WAS PLACED INTO EMERGENCY MODE STAGE 1 TO RUN PATIENT TREATMENTS UNTIL THE SYSTEM COULD BE TESTED. THE BIOMED STATED DURING TESTING THAT STAGE 2 WOULD NOT POWER ON. WHEN ATTEMPTING TO POWER ON STAGE 2, THE MPS TRIPS (THE GREEN BUTTON POPS OUT) AND THE UNIT POWERS DOWN IMMEDIATELY. THE BIOMED ALSO REPORTED THAT SPARKING WAS OBSERVED FROM THE ¿L2¿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