BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABPLUS, HF 2000

    MDR report key: 18006121 · Received October 25, 2023

    Report

    Report Number
    3010850471-2023-00088
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 1, 2024
    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: PHYSICAL EVALUATION OF A SAMPLE WAS NOT REQUIRED FOR THIS CASE. THE REPORTED ISSUE WAS CONFIRMED USING THE PROVIDED INFORMATION. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE A BAD ELECTRICAL CONTACT OF THE WIRING AT THE MOTOR PROTECTION SWITCH. THE DAMAGE RESULTED FROM EITHER (1) THE ELECTRICAL CONTACT AT THE MOTOR PROTECTION SWITCH PUMP P1(S) RUNNING WITH ONLY TWO LINE CONDUCTORS OR (2) THE INNER BIMETAL CONTACT OF THE MOTOR PROTECTION TRIPPING FROM INCREASED TEMPERATURE CAUSED BY THE TRANSITION RESISTANCE OF THE ELECTRICAL CONTACT. BOTH ISSUES RESULT IN HIGHER CURRENTS AND HIGHER THERMAL ENERGY, AND ULTIMATELY THERMAL DECOMPOSITION. THIS FAILURE IS A KNOWN ISSUE. 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 SWITCH (THE MOTOR PROTECTION SWITCH IN THE CURRENT DESIGN). THE IMPROVED DESIGN IS CURRENTLY NOT AVAILABLE FOR THE AFFECTED MARKET SEGMENT, BUT THE RELEASE IS PLANNED BY COMPLETION OF THE DESIGN CHANGE. ACCORDING TO THE PROVIDED INFORMATION, THE MOTOR PROTECTION SWITCH, CONTACTOR AND THE WIRING WERE REPLACED TO SOLVE THE ISSUE. THE CURRENT STATUS OF THE MACHINE IS UNKNOWN. IT IS RECOMMENDED, IF NOT ALREADY DONE, TO REPLACE THE WIRING AND THE MOTOR PROTECTION SWITCH IN STAGE 1 AND STAGE 2 WITH THE AVAILABLE DESIGN. ONLY INSTALLATION OF MANUFACTURER SPARE PARTS IS ADVISED.

    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 WIRES AND TERMINALS (16 AWG-GAUGE) ON THE PUMP CONTACTOR AS WELL AS THE POWER CABLES WERE OVERHEATED RESULTING IN EQUIPMENT FAILURE. 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.

    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 WIRES AND TERMINALS (16 AWG-GAUGE) ON THE PUMP CONTACTOR AS WELL AS THE POWER CABLES WERE OVERHEATED RESULTING IN EQUIPMENT FAILURE. 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
    1733653 AQUABPLUS, HF 2000 SUBSYSTEM, WATER PURIFICATION FIP VIVONIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown