AQUABPLUS, HF 2500

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT AN AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM SUSTAINED THERMAL DAMAGE. THE AFFECTED PARTS WERE LOCATED IN THE ELECTRICAL SYSTEM. THERE WAS HEATING DAMAGE TO THE PRINCIPAL SWITCH, TRIPS, AND REMAINS IN SUPPLY MODE FOR 24 HOURS EVEN THOUGH THE PERMEATE TANK IS FULL. IT WAS FOUND THAT THE LOW LEVEL SENSOR WITH CONTACT ALWAYS CLOSED. THE MAIN SWITCH OUTPUT WIRES TOWARDS THE CONTACTOR HAVE A VERY THIN DIAMETER THEN OVERHEATING OCCURS. THE PRINCIPAL SWITCH AND ASSOCIATED ELECTRICAL WIRING WERE REPLACED TO RESOLVE THE IDENTIFIED THERMAL DAMAGE. IN ADDITION, THE FLOAT IS CHECKED AND LEVELS ADJUSTED WHICH WORKED. IT WAS NOTED THAT THE SYSTEM WAS IN STANDBY WHEN THE TANK IS FULL, WHICH IS NECESSARY. THE CAPACITIVE SENSOR AND OUTPUT CABLES ON THE MAIN SWITCH WILL BE REPLACED ONCE THE SYSTEM IS PREPARED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE. A SAMPLE WAS NOT REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

INVESTIGATION: A REVIEW FOR SIMILAR COMPLAINTS IS NOT REQUIRED IN THIS CASE. THE FAILURE PATTERN IS KNOWN AND CAPA 1584972 COULD BE ASSIGNED TO THIS COMPLAINT RECORD, ANY THRESHOLD EXCEEDANCE IS NOT RELEVANT. THE REPORTED EVENT CAN BE CONFIRMED BY THE PROVIDED INFORMATION. NO RELATION TO ANY RISK FOR PATIENT, USER OR THIRD. NO INFORMATION WAS PROVIDED THAT ACUTE PATIENTS WERE INVOLVED IN RELATION TO THE REPORTED CASE. NO FURTHER INVESTIGATIONS WITHIN THE COMPLAINT ARE REQUIRED, A ROOT CAUSE ANALYSIS IS IN PROGRESS. THE COMPLAINT INVESTIGATION DETERMINES A FAILURE CAUSE A BAD CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH AS FAILURE CAUSE. THE MOTOR PROTECTION SWITCH, CONTACTOR, AND THE WIRING WERE REPLACED TO SOLVE THE ISSUE.

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

IT WAS REPORTED TO FRESENIUS THAT AN AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM SUSTAINED THERMAL DAMAGE. THE AFFECTED PARTS WERE LOCATED IN THE ELECTRICAL SYSTEM. THERE WAS HEATING DAMAGE TO THE PRINCIPAL SWITCH, TRIPS, AND REMAINS IN SUPPLY MODE FOR 24 HOURS EVEN THOUGH THE PERMEATE TANK IS FULL. IT WAS FOUND THAT THE LOW LEVEL SENSOR WITH CONTACT ALWAYS CLOSED. THE MAIN SWITCH OUTPUT WIRES TOWARDS THE CONTACTOR HAVE A VERY THIN DIAMETER THEN OVERHEATING OCCURS. THE PRINCIPAL SWITCH AND ASSOCIATED ELECTRICAL WIRING WERE REPLACED TO RESOLVE THE IDENTIFIED THERMAL DAMAGE. IN ADDITION, THE FLOAT IS CHECKED AND LEVELS ADJUSTED WHICH WORKED. IT WAS NOTED THAT THE SYSTEM WAS IN STANDBY WHEN THE TANK IS FULL, WHICH IS NECESSARY. THE CAPACITIVE SENSOR AND OUTPUT CABLES ON THE MAIN SWITCH WILL BE REPLACED ONCE THE SYSTEM IS PREPARED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE. A SAMPLE WAS NOT REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.