BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ

    MDR report key: 8206391 · Received December 28, 2018

    Report

    Report Number
    MW5082696
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 21, 2018
    Report Date
    December 27, 2018
    Manufacturer
    EPIC MEDICAL PTE 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

    ON CALL RN RECEIVED CALL FROM PATIENT'S WIFE REPORTING MEDICATION IS NOT INFUSING. HE HAD BEEN CONNECTED FOR OVER 45 MINUTES AND THE BALL HAD NOT DECREASED. SHE REPORTED TO ON-CALL RN THAT SHE ALREADY FLUSHED THE LINE AGAIN AND DISCONNECTED THE TUBING TO CHECK FOR DRIPS 4 TIMES. THE SMARTEZ PUMP FILLED WITH CEFTRIAXONE 2G/0.9% SODIUM CHLORIDE 100 ML DRIPPED UPON DISCONNECTION FROM IV LINE. PATIENT USED ANOTHER SMARTEZ PUMP AND INFUSED [SMARTEZ MODEL # SE0200-100, LOT: S8E45].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044380 SMARTEZ PUMP, INFUSION, ELASTOMERIC MEB EPIC MEDICAL PTE LTD. SE0200-100 S8E45

    Patients

    Seq Age Sex Outcome Treatment
    1