AQUABPLUS, HF 2000
Received Oct 15, 2023 · Event occurred Aug 1, 2023
Report 3010850471-2023-00079 · MDR key 17936890
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MANUFACTURER DETERMINED THE CAUSE OF THE REPORTED FAILURE TO BE A BAD ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH. THE BAD CONTACT AT THE MOTOR PROTECTION SWITCH EITHER (1) RUNS THE PUMP P1 WITH TWO LINE CONDUCTORS RESULTING IN HIGHER CURRENT AND THERMAL ENERGY OR (2) THE INNER BIMETAL CONTACT OF THE MOTOR PROTECTION TRIPS DUE TO INCREASED TEMPERATURE CAUSED BY THE TRANSITION RESISTANCE OF THE CONTACT. IN BOTH CASES THE MOTOR PROTECTION SWITCH TRIPS AND THE DEVICE IS POWERED OFF. THE RESULT IS THERMAL DAMAGE AT THE THE MOTOR PROTECTION SWITCH FROM INCREASED HEAT RADIATION. THIS FAILURE IS A KNOWN ISSUE. A ROOT CAUSE ANALYSIS IS IN PROGRESS. THE DESIGN OF THE BLADE RECEPTACLE AT THE MOTOR PROTECTION SWITCH WAS DETERMINED TO BE INADEQUATE. CORRECTIVE/PREVENTIVE ACTIONS WILL BECOME AVAILABLE WITH AN IMPROVED DESIGN FOR THE ELECTRICAL MONITOR, WHICH INCLUDES THE WIRING AT THE MAIN SWITCH. THE DESIGN CHANGE IS APPROVED BUT CURRENTLY NOT IMPLEMENTED. THE IMPROVED DESIGN IS CURRENTLY NOT AVAILABLE FOR THE AFFECTED MARKET SEGMENT, BUT THE RELEASE IS PLANNED BY COMPLETION OF THE DESIGN CHANGE.
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 12,958 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.
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 12,958 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.
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 12,958 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.