AQUABPLUS, HF 2000
Received Oct 15, 2023 · Event occurred Aug 1, 2023
Report 3010850471-2023-00076 · MDR key 17936889
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 DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WERE VISUAL INDICATIONS OF OVERHEATING ON THE WIRING AND TERMINALS OF THE MOTOR PROTECTION SWITCH (MPS). THE MPS WAS ALSO HOT TO THE TOUCH. THE MPS AND WIRING WERE REPLACED TO RESOLVE THE THERMAL DAMAGE. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE RO SYSTEM HAS APPROXIMATELY (B)(4) HOURS. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE.
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. 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 ONLY WITH TWO LINE CONDUCTORS AND RESULTING IN HIGHER CURRENT AND HIGHER THERMAL ENERGY. OR THE INNER BIMETAL CONTACT OF THE MOTOR PROTECTION DO TRIP DUE TO INCREASED TEMPERATURE CAUSED BY THE TRANSITION RESISTANCE OF THE ELECTRICAL CONTACT. IN BOTH CASES THE MOTOR PROTECTION SWITCH TRIPS AND THE DEVICE IS POWERED OFF. THIS IS A KNOWN FAILURE. 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. THE IMPROVED DESIGN IS CURRENTLY NOT AVAILABLE FOR THE AFFECTED MARKET SEGMENT, BUT THE RELEASE IS PLANNED BY COMPLETION OF THE DESIGN CHANGE IMPLEMENTATION. IT IS RECOMMENDED TO REPLACE, IF NOT ALREADY DONE, THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 WITH THE AVAILABLE DESIGN.
Description of Event or Problem
IT WAS REPORTED TO FRESENIUS THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THERE WERE VISUAL INDICATIONS OF OVERHEATING ON THE WIRING AND TERMINALS OF THE MOTOR PROTECTION SWITCH (MPS). THE MPS WAS ALSO HOT TO THE TOUCH. THE MPS AND WIRING WERE REPLACED TO RESOLVE THE THERMAL DAMAGE. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE RO SYSTEM HAS APPROXIMATELY 18,693 HOURS. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY. THERE WERE NO LOCAL POWER GRID ISSUES ON OR AROUND THE REPORTED EVENT DATE. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THE IDENTIFIED THERMAL DAMAGE.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.