AQUABPLUS, HF 500
Received Oct 25, 2023 · Event occurred Apr 12, 2023
Report 3010850471-2023-00083 · MDR key 18006147
Device
Product problems
- Thermal Decomposition of Device
- Sparking
- Thermal Decomposition of Device
- Sparking
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 IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. A SWITCH WAS BURNED AND ITS PINS WERE LOOSE. THE MACHINE HAS APPROXIMATELY 5,687 OPERATING HOURS. A REPLACEMENT SWITCH WAS ORDERED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE DEVICE TURNS OFF IMMEDIATELY WHEN TURNED ON. THE SUSPECTED CAUSE OF THIS FAILURE IS VOLTAGE VARIATION. THERE ARE NO ALARM CODES ASSOCIATED WITH THE REPORTED ERROR. SPARKING AND A BURNING SMELL WERE ALSO OBSERVED. IT WAS CONFIRMED THAT THE THERMAL OVERLOAD RELAY TRIPPED AS WELL. NO BLOWN FUSES WERE FOUND IN THE LOCAL POWER SUPPLY. NO LOCAL POWER GRID ISSUES WERE OBSERVED ON OR AROUND THE REPORTED EVENT DATE. THE EQUIPMENT¿S POWER SWITCH AND PUMP WERE REPLACED TO RESOLVE THE REPORTED ISSUE. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR HARM TO ANY INDIVIDUALS REGARDING THE REPORTED ISSUE.
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.
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 THERMAL DAMAGE WAS IDENTIFIED IN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. A SWITCH WAS BURNED AND ITS PINS WERE LOOSE. THE MACHINE HAS APPROXIMATELY 5,687 OPERATING HOURS. A REPLACEMENT SWITCH WAS ORDERED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE DEVICE TURNS OFF IMMEDIATELY WHEN TURNED ON. THE SUSPECTED CAUSE OF THIS FAILURE IS VOLTAGE VARIATION. THERE ARE NO ALARM CODES ASSOCIATED WITH THE REPORTED ERROR. SPARKING AND A BURNING SMELL WERE ALSO OBSERVED. IT WAS CONFIRMED THAT THE THERMAL OVERLOAD RELAY TRIPPED AS WELL. NO BLOWN FUSES WERE FOUND IN THE LOCAL POWER SUPPLY. NO LOCAL POWER GRID ISSUES WERE OBSERVED ON OR AROUND THE REPORTED EVENT DATE. THE EQUIPMENT¿S POWER SWITCH AND PUMP WERE REPLACED TO RESOLVE THE REPORTED ISSUE. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR HARM TO ANY INDIVIDUALS REGARDING THE REPORTED ISSUE.