BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 23541752 · Received November 12, 2025

    Report

    Report Number
    MW5178781
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 4, 2025
    Report Date
    November 10, 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

    IBC FROM THE PT'S WIFE, (B)(6), SHE SAID WHEN THEY WENT TO CHANGE THE VIAL ON SATURDAY THEY NOTICED THE SYRINGE WAS STILL FULL, NO MEDICATION WAS DELIVERED. SHE SAID HER HUSBAND WASN'T FEELING WELL ALL DAY SATURDAY. SHE SAID THE MACHINE SAID IT WAS RUNNING, SHE SAID THERE WAS NO ALARM. THERE WAS NO ISSUE WITH THE CONNECTION. SHE SAID THEY REPLACED THE VIAL ON SATURDAY AND IT HAS BEEN WORKING SINCE. COUNSELED TO INFORM HIS MD. NO FURTHER INFO TO PROVIDE. PT CODE: 2359. DEVICE CODE: 2338. REF REPORT: MW5178782.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119133 PUMP VYAFUSER KIT PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male VYALEV SDV