BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 23276111 · Received October 14, 2025

    Report

    Report Number
    MW5177227
    Event Type
    Malfunction
    Date Received
    October 14, 2025
    Date of Event
    July 25, 2025
    Report Date
    October 8, 2025
    Manufacturer
    PHILLIPS-MEDISIZE A/S
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CROSS-BODY STRAP IN PUMP KIT BROKE. RN AMBASSADOR FROM ABBVIE WITNESSED. PATIENT NEEDED REPLACEMENT SHIPPED. DOSING: ADMINISTER THE CONTENTS OF 1 VIAL UNDER THE SKIN FOR UP TO 24 HOURS EACH DAY. LOADING DOSE: 1.0 ML, CONTINUOUS DOSE: 0.27 ML.HR (0.24-0.30 ML/HR), EXTRA DOSE: 0.25 ML. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198867 PUMP VYAFUSER KIT PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female PUMP VYAFUSER KIT