BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART EZ PUMP

    MDR report key: 9260563 · Received October 30, 2019

    Report

    Report Number
    MW5090791
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 18, 2019
    Report Date
    October 28, 2019
    Manufacturer
    EPIC MEDICAL PTE LTD.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMART EZ PUMP (5 FU) TO INFUSE OVER 48 HOURS. PATIENT RETURNED AFTER 48 HOURS WITH PUMP NOTED NOT TO BE DEFLATING/INFUSING. PUMP APPEARED TO BE FULL INDICATING PATIENT DID NOT RECEIVE ANY OF THE 5FU OF MEDICATION AS PRESCRIBED. FDA SAFETY REPORT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052756 SMART EZ PUMP PUMP, INFUSION, ELASTOMERIC MEB EPIC MEDICAL PTE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR