BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ 100 ML, 200 ML/HR

    MDR report key: 8146776 · Received December 7, 2018

    Report

    Report Number
    MW5081970
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    October 17, 2018
    Report Date
    December 6, 2018
    Manufacturer
    EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SMARTEZ 200 ML/HR 100 ML VOLUME (LOT# UNKNOWN) FILLED WITH IMIPENEM/CILASTATIN 500 MG, WOULD NOT INFUSE WHEN ATTACHED TO THE PATIENT¿S IV CATHETER. IT DRIPPED WHEN NOT CONNECTED TO THE PATIENT. PATIENT WAS ABLE TO INFUSE WITH ANOTHER SMARTEZ DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980275 SMARTEZ 100 ML, 200 ML/HR PUMPM, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1