BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ

    MDR report key: 25080980 · Received May 5, 2026

    Report

    Report Number
    25080980
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 14, 2026
    Manufacturer
    EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE FOUND FLUOROURACIL PUMP LEAKING BEFORE IT GIVES TO PATIENT, PHARMACY REMADE A NEW PUMP. MOST LIKELY LEAKING IS CAUSED BY DEFECTIVE PUMP. PUMP MANUFACTURER: SMARTEZ PUMP, LOT: C251341, EXPIRATION DATE: 12/22/2028

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593732 SMARTEZ PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED C251341

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown Other