BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP VYAFUSER KIT

    MDR report key: 23415714 · Received October 29, 2025

    Report

    Report Number
    MW5178183
    Event Type
    Injury
    Date Received
    October 29, 2025
    Report Date
    October 24, 2025
    Manufacturer
    PHILLIPS-MEDISIZE A/S
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT AND PATIENT'S SISTER STATED THAT THEY HAVE TRIED REPLACING THE BATTERY. EACH TIME THEY TRY, THE PUMP WILL STATE PREPARING AND THEN STOPS. WHEN IT STOPS IT INDICATES A PROBLEM WAS DETECTED. THEY HAVE TRIED USING BOTH BATTERIES. ONE IS COMPLETELY CHARGED. THEY REACHED OUT TO THE NURSE AMBASSADOR WHO FELT THE PUMP WAS DEFECTIVE. AFTER TROUBLESHOOTING, A NEW PUMP IS BEING SENT. SISTER ALSO REPORTED THAT PATIENT EXPERIENCED AN ABSCESS BACK IN (B)(6) 2025 AND HAD ANOTHER ONE ABOUT 2 WEEKS AGO WHERE HE WENT TO THE ER AND WAS PROVIDED ANTIBIOTICS. HE IS DOING MUCH BETTER NOW AND MD IS AWARE. UNKNOWN IF PATIENT MISSED DOSE. UNKNOWN IF PATIENT EXPERIENCED ANY ADVERSE EVENTS. PRODUCT IS AVAILABLE FOR RETURN. UNKNOWN IF MD AWARE. NO FURTHER INFORMATION, DETAILS, OR DATES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541089 PUMP VYAFUSER KIT PUMP, INFUSION FRN PHILLIPS-MEDISIZE A/S

    Patients

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