BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 25094954 · Received May 6, 2026

    Report

    Report Number
    MW5187762
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Report Date
    May 1, 2026
    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

    PT REPORTS THE PUMP FOR VYALEV WILL NOT TO TURN ON. UNKNOWN IF DOSE WAS MISSED, UNKNOWN IF PT EXPERIENCED AN ADVERSE EVENT, UNKNOWN IF DEFECTIVE RX IS AVAILABLE FOR RETURN, UNKNOWN IF MD IS AWARE, NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494360 PUMP VYAFUSER KIT PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ORTHERA.| VIAL ADAPTER VENTED TRNSFR.| VYALEV SDV.