BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ

    MDR report key: 8129261 · Received December 3, 2018

    Report

    Report Number
    MW5081820
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 29, 2018
    Report Date
    November 30, 2018
    Manufacturer
    EPIC INTERNATIONAL (THAILAND) CO., LTD.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SLOW FLOW WITH VANCOMYCIN 2 G/NS 250 ML SMART EZ {SE0175-250; LOT: S8H02} AND CEFTRIAXONE 2 G/NS 100 ML SMART EZ {SE0200-100; LOT S8D33}; 100 ML, 200 ML /HR AND SMART EZ 250 ML, 175 ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963035 SMARTEZ PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL (THAILAND) CO., LTD. S38D33
    963036 SMARTEZ PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL (THAILAND) CO., LTD. S8H02

    Patients

    Seq Age Sex Outcome Treatment
    1