BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ PUMP

    MDR report key: 8436326 · Received March 19, 2019

    Report

    Report Number
    MW5085019
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    March 14, 2019
    Report Date
    March 18, 2019
    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

    SMARTEZ DEVICE CONTAINING VANCOMYCIN 1.25GM/NS 250ML (175/250ML, LOT #6120560, EXP 03/31/2019). PT CALLED AND EXPLAINED DEVICE WOULD NOT INFUSE AFTER OVER 30 MINS. PT UNHOOKED DEVICE AND FLUSHED WITH BOTH NS AND HEPARIN, STILL NO IMPROVEMENT WITH INFUSION. DEVICE SHOWS EVIDENCE OF SLOW/FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227895 SMARTEZ PUMP PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL (THAILAND) CO., LTD. SE0175-250 6120560

    Patients

    Seq Age Sex Outcome Treatment
    1