BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX

    MDR report key: 10057160 · Received May 14, 2020

    Report

    Report Number
    3012307300-2020-04426
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    March 19, 2020
    Report Date
    May 14, 2020
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER TEXT: MW 5093886.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER IS HAVING ISSUES WITH MEDFUSION 4000 SYRINGE PUMP-POWER RELATED IN NATURE. PUMPS FAILING DURING INFUSION WITHOUT WARNING, OR GIVING SOME FORM OF A WARNING INVOLVING THE BATTERY. ALL OF THESE MAY OCCUR EVEN WHILE PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522613 MEDEX SYRINGE INFUSION PUMP FRN 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1