BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ ELASTOMERIC INFUSION PUMP

    MDR report key: 8164532 · Received December 13, 2018

    Report

    Report Number
    MW5082119
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    December 11, 2018
    Report Date
    December 12, 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

    SMART EZ PUMP (SE0200-100, LOT# UNKNOWN) CONTAINING ZOSYN 4.5 GRAMS IN 0.9% SODIUM CHLORIDE 100 ML WOULD NOT INFUSE. PATIENT TRIED TO DISCONNECT / RECONNECT 6 TIMES, CONFIRMED IT WAS DRIPPING EACH TIME. PATIENT THEN CONNECTED TO THE OTHER EXTENSION TUBING AND IT INFUSED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998230 SMARTEZ ELASTOMERIC INFUSION PUMP SMARTEZ PUMP MEB EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP. SE0200-100

    Patients

    Seq Age Sex Outcome Treatment
    1