BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 PUMP

    MDR report key: 20008090 · Received August 20, 2024

    Report

    Report Number
    3012307300-2024-07816
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    June 1, 2024
    Report Date
    August 16, 2024
    Manufacturer
    6000 NATHAN LN N
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: FACILITY NAME: (B)(6). H3/H6: ONE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND THE DEVICE TO BE IN USED CONDITION. A PRIMARY AUDIBLE ALARM POWER ON SELF-TEST (POST) AND A ACU WATCHDOG ALARM WERE REVEALED IN THE EVENT HISTORY LOG. FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM; HOWEVER, IT WAS VERIFIED IN THE EVENT HISTORY LOG. THE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. AD A PREVENTATIVE MEASURE THE SPEAKER WAS REPLACED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE EXHIBITED AN ACU WATCHDOG FAILURE ERROR CODE. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350008 MEDFUSION 4000 PUMP PUMP, INFUSION FRN 6000 NATHAN LN N 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown