BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 24418336 · Received February 23, 2026

    Report

    Report Number
    MW5184254
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Report Date
    February 16, 2026
    Manufacturer
    UNKNOWN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RPH SPOKE WITH (B)(6) (RN WITH MANUFACTURER) WHO REPORTS THAT PATIENT HAS NOTICED OVER THE LAST 4-5 DAYS THAT¿S PUMP IS NOT RUNNING THE FULL 24 HOURS PER DAY. INSTEAD, THE PUMP IS RUNNING AT ABOUT 21 HOURS PER DAY. PATIENT HAS NOTICED EVEN AT A LOWER RATE. THERE¿S ONLY 1-2 ML LEFT IN SYRINGE. NURSE CONFIRMED BATTERY HAS BEEN CHARGED. CAMILE N(RN) APPROVED REPLACE WITH MANUFACTURER AND REFERENCE # (B)(4). NO FURTHER INFO. ADMINISTER THE CONTENTS OF 1 VIAL UNDER THE SKIN FOR UP TO 24 HOURS EACH DAY. LOADING DOSE: 0.8 ML, CONTINUOUS DOSE: 0.33 ML/HR (0.31 - 0.35 ML/HR), EXTRA DOSE: 0.25 ML WITH 1 HOUR LOCK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473882 PUMP VYAFUSER KIT PUMP, INFUSION FRN UNKNOWN 20064131

    Patients

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