BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 22039473 · Received May 16, 2025

    Report

    Report Number
    MW5170533
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    March 29, 2025
    Report Date
    May 14, 2025
    Manufacturer
    ABBVIE INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DOSING - ADMINISTER THE CONTENTS OF 1 VIAL UNDER THE SKIN FOR UP TO 24 HOURS EACH DAY. LOADING DOSE: 0.5ML, CONTINUOUS DOSE: 0.32ML/HR (0.26ML/HR-0.35ML/HR), EXTRA DOSE: 0.3ML. PATIENT'S WIFE REPORTED DEFECTIVE VYALEV PUMP. THE PUMP STARTED GIVING THEM ISSUES ON SATURDAY. THE PUMP WOULD PROMPT WITH MESSAGE "REMOVE BATTERY, WAIT 10 MIN, RE-INSERT BATTERY AND REFER TO DIRECTIONS". THEY FOLLOWED THOSE STEPS, BUT THEN THE PUMP WOULD BEEP AND PRESENT A SCREEN WITH A YIELD SIGN AND EXCLAMATION POINT AND MESSAGE "PROBLEM DETECTED. PUMP IS STOPPED." REPEATED SEVERAL TIMES. VYALEV NURSE ADVISED THIS IS NOT SOMETHING THAT CAN BE FIXED. PUMP NEEDS REPLACED. OVERNIGHT ORDER BEING SENT. PT HAD ORAL CARBIDOPA/LEVODOPA ON HAND TO USE INSTEAD OF PUMP IN THE MEANTIME. NO ADDITIONAL INFORMATION KNOWN. MANUFACTURER IS ABBVIE. PUMP SERIAL # (B)(6). PATIENT HAS PUMP FOR RETURN. PARKINSON'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166697 PUMP VYAFUSER KIT PUMP, INFUSION FRN ABBVIE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male