AQUABPLUS, HF 2500
Received Oct 10, 2023 · Event occurred Jun 17, 2021
Report 3010850471-2023-00070 · MDR key 17905153
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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, AND THE TERMINALS AND ELECTRICAL WIRING BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR HAD "SULPHATED." THE MACHINE HAD APPROXIMATELY 12,042 OPERATING HOURS WHEN THE REPORTED ISSUE WAS DISCOVERED. THE PRINCIPAL SWITCH AND ASSOCIATED ELECTRICAL WIRING WERE REPLACED TO RESOLVE THE IDENTIFIED THERMAL DAMAGE. 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
CORRECTION: B5 (MACHINE HOURS HAVE NOW BEEN INCLUDED) 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, AND THE TERMINALS AND ELECTRICAL WIRING BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR HAD "SULPHATED." THE MACHINE HAD APPROXIMATELY 12,042 OPERATING HOURS WHEN THE REPORTED ISSUE WAS DISCOVERED. THE PRINCIPAL SWITCH AND ASSOCIATED ELECTRICAL WIRING WERE REPLACED TO RESOLVE THE IDENTIFIED THERMAL DAMAGE. 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
PLANT INVESTIGATION: NO SAMPLES WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE REPORTED ISSUE HAS BEEN CONFIRMED BASED ON THE PROVIDED INFORMATION. THE MANUFACTURER DETERMINED POOR ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH TO BE THE CAUSE OF THE REPORTED ISSUE. THE REPORTED FAILURE IS A KNOWN ISSUE. IN THE CURRENT DESIGN THE MOTOR PROTECTION SWITCH IS ALSO THE MAIN SWITCH OF THE DEVICE. THE DESIGN OF THE BLADE RECEPTACLE AT THE MOTOR PROTECTION SWITCH IS INADEQUATE. THE BAD ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH RESULTS IN THE PUMP P1(S) RUNNING WITH ONLY TWO LINE CONDUCTORS RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE INNER BIMETAL CONTACT OF THE MOTOR PROTECTION CAN ALSO TRIP DUE TO INCREASED TEMPERATURE CAUSED BY THE TRANSITION RESISTANCE OF THE ELECTRICAL CONTACT. IN BOTH CASES THE MOTOR PROTECTION SWITCH TRIPS AND POWERS OFF THE DEVICE. A ROOT CAUSE ANALYSIS IS IN PROGRESS AND CORRECTIVE/PREVENTIVE ACTIONS WILL BECOME AVAILABLE WITH AN IMPROVED DESIGN FOR THE ELECTRICAL MONITOR, WHICH INCLUDES THE WIRING AT THE MAIN SWITCH. THE IMPROVED DESIGN IS CURRENTLY NOT AVAILABLE FOR THE AFFECTED MARKET SEGMENT, BUT THE RELEASE IS PLANNED BY COMPLETION OF THE IMPLEMENTATION OF THE DESIGN CHANGE.
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, AND THE TERMINALS AND ELECTRICAL WIRING BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR HAD "SULPHATED." THE PRINCIPAL SWITCH AND ASSOCIATED ELECTRICAL WIRING WERE REPLACED TO RESOLVE THE IDENTIFIED THERMAL DAMAGE. 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.