AQUABPLUS, HF 1500
Received Dec 5, 2023 · Event occurred Aug 1, 2023
Report 3010850471-2023-00103 · MDR key 18267664
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 THERMAL DAMAGE WAS SUSTAINED TO THE WIRING AND TERMINALS OF THE MOTOR PROTECTION SWITCH (MPS) OF THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE MPS WAS HOT TO THE TOUCH. VISUAL INDICATIONS OF OVERHEATING WERE PRESENT. THE MACHINE HAD APPROXIMATELY 16,598 OPERATING HOURS AT THE TIME OF THE REPORTED ISSUE. THE CUSTOMER CONFIRMED THERE WERE NO BLOWN FUSES IDENTIFIED IN THE LOCAL POWER SUPPLY NOR WERE THERE ANY LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THE MPS AND WIRING WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUALS AS A RESULT OF THE REPORTED THERMAL DAMAGE. THE SAMPLES WERE REPORTED TO BE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.
Additional Manufacturer Narrative
PLANT INVESTIGATION: THE COMPLAINT INVESTIGATION DETERMINED A BAD ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH AS THE FAILURE CAUSE. THE DESIGN OF THE BLADE RECEPTACLE AT THE MOTOR PROTECTION SWITCH HAS BEEN DETERMINED TO BE INADEQUATE. IN THE CURRENT DESIGN THE MOTOR PROTECTION SWITCH IS ALSO THE MAIN SWITCH OF THE DEVICE. THE PUMP P1 COULD POTENTIALLY ONLY RUN WITH TWO LINE CONDUCTORS RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. THE INNER BIMETAL CONTACT OF THE MOTOR PROTECTION COULD ALSO TRIP DUE TO INCREASED TEMPERATURE CAUSED BY THE TRANSITION RESISTANCE OF THE ELECTRICAL CONTACT. IN BOTH CASES THE MOTOR PROTECTION SWITCH CAN TRIP AND POWER OFF THE DEVICE. THE MOTOR PROTECTION SWITCH COULD ALSO BECOME THERMALLY DAMAGED WITH INCREASED HEAT RADIATION. A ROOT CAUSE ANALYSIS IS IN PROGRESS AND CORRECTIVE/PREVENTIVE ACTIONS WILL BE COME 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. A REVIEW OF THE HISTORY RECORDS OR COMPLAINT HISTORY IS NOT APPLICABLE IN THIS INVESTIGATION, AS IT WAS CONFIRMED THAT THIS IS A KNOWN ISSUE AND THE DEVICE WAS MANUFACTURED WITH THE ORIGINAL SWITCH DESIGN.