BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABPLUS, HF 2000

    MDR report key: 18006071 · Received October 25, 2023

    Report

    Report Number
    3010850471-2023-00085
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    February 7, 2022
    Report Date
    December 6, 2023
    Manufacturer
    VIVONIC GMBH
    Product Code
    FIP
    PMA / PMN Number
    K143617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. BASED ON THE AVAILABLE PHOTOGRAPHS, LOCAL PARTS WERE USED TO REPAIR THE MACHINE AND RESOLVE THE PROBLEM. ONLY ORIGINAL SPARE PARTS ARE ADVISED FOR USE PER THE SERVICE MANUAL AND INSTRUCTIONS FOR USE (IFU). THE CURRENT STATUS OF THE MACHINE IS UNKNOWN. 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 · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE AFFECTED COMPONENTS WERE ISOLATED TO THE IGNITION SWITCH GROUP, ELECTRICAL CONTACTOR OF THE PRESSURE PUMP, AND ELECTRICAL WIRING OF THE CONNECTION BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR THAT FEEDS THE PRESSURE PUMP OF THE AQUABPLUS EQUIPMENT. THE TERMINALS OF THE POWER SUPPLY CABLES ON THE PUMP CONTACTOR WERE SULFATED AND OVERHEATED. ONE OF THE POWER CABLES WAS DAMAGED AS A RESULT OF FALSE CONTACT MADE WITH THE PUMP CONTACTOR. THE MACHINE HAS APPROXIMATELY (B)(4) OPERATING HOURS. THE TERMINALS AND FAULTY CONTACTORS WERE REPLACED TO RESOLVE THE REPORTED DAMAGE. THE CABLE GAUGE WAS ALSO REPLACED TO ALLOW FOR A GREATER LOAD OF CURRENT INTENSITY. IT WAS NOT REPORTED WHETHER A SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF ENCOUNTERING THE THERMAL DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE AFFECTED COMPONENTS WERE ISOLATED TO THE IGNITION SWITCH GROUP, ELECTRICAL CONTACTOR OF THE PRESSURE PUMP, AND ELECTRICAL WIRING OF THE CONNECTION BETWEEN THE MAIN IGNITION SWITCH AND THE ELECTRICAL CONTACTOR THAT FEEDS THE PRESSURE PUMP OF THE AQUABPLUS EQUIPMENT. THE TERMINALS OF THE POWER SUPPLY CABLES ON THE PUMP CONTACTOR WERE SULFATED AND OVERHEATED. ONE OF THE POWER CABLES WAS DAMAGED AS A RESULT OF FALSE CONTACT MADE WITH THE PUMP CONTACTOR. THE MACHINE HAS APPROXIMATELY 4,798 OPERATING HOURS. THE TERMINALS AND FAULTY CONTACTORS WERE REPLACED TO RESOLVE THE REPORTED DAMAGE. THE CABLE GAUGE WAS ALSO REPLACED TO ALLOW FOR A GREATER LOAD OF CURRENT INTENSITY. IT WAS NOT REPORTED WHETHER A SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR REPORTED PERSONAL HARM TO ANY INDIVIDUAL AS A RESULT OF ENCOUNTERING THE THERMAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023048 AQUABPLUS, HF 2000 SUBSYSTEM, WATER PURIFICATION FIP VIVONIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown