BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP

    MDR report key: 13308974 · Received January 20, 2022

    Report

    Report Number
    3012307300-2022-01265
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Report Date
    January 20, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ROOT CAUSE OR PROBLEM WAS FOUND, PUMP IS INFUSING AS INTENDED. NO ERROR WHICH RELATED TO INFUSING PROBLEM WAS FOUND IN EHL. OCCLUSION TEST AND SYRINGE DELIVERY TEST WERE PERFORMED MULTIPLE TIMES AND NO PROBLEM WAS FOUND DURING ANY OF THE INFUSION. DEVICE WAS IN GOOD CONDITION WITH NO APPEARANCE OF ANY PHYSICAL DAMAGED. PERFORMED PM MAINTENANCE AND ALL FUNCTIONAL TESTING. CLEANED AND GREASED PUMP.

    Description of Event or Problem · 0

    ORACLE RO : 1173978 WHEN INFUSING NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68940 MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown