BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 23346618 · Received October 20, 2025

    Report

    Report Number
    MW5177672
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Report Date
    October 15, 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

    PATIENT'S SISTER REPORTED PATIENT'S LOADING DOSE FEATURE IS NOT DISPLAYING ON THE PUMP. PATIENT REPORTED THIS ISSUE TO THE VYALEV RN PUMP SUPPORT TEAM AND DEEMED NEW PUMP IS NEEDED. PATIENT IS STILL ABLE TO RECEIVE CONTINUOUS DOSES AND EXTRA DOSES AND DOES NOT NEED TO TRANSITION TO ORAL MEDICATION. PATIENT RAN HIS HIGH DOSE FOR 1 HOUR TO REPLACE THE LOADING DOSE THAT WAS NOT AVAILABLE AND THIS WAS SUFFICIENT, BUT REPLACEMENT IS STILL NEEDED. CAREGIVER IS NOT SURE OF PATIENT'S CURRENT DOSE SETTINGS AND WE WILL NEED TO CONFIRM WITH PROVIDER BEFORE SHIPPING. NO MISSED DOSE OR ADVERSE EVENTS REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. PUMP LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. NO FURTHER INFORMATION PROVIDED. INDICATION: PARKINSON'S DISEASE WITHOUT DYSKINESIA, WITHOUT MENTION OF FLUCTUATIONS. DOSE AND FREQUENCY: ADMINISTER THE CONTENTS OF 2 VIALS UNDER THE SKIN FOR UP TO 24 HOURS EACH DAY. LOADING DOSE: 1.1 ML, CONTINUOUS DOSE: 0.38 MILLILITER/HOUR (0.35 - 0.4 ML/HR), EXTRA DOSE: 0.15 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230042 PUMP VYAFUSER KIT PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male VYALEV SINGLE DOSE VIAL.