BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED AMBULATORY INFUSION PUMP

    MDR report key: 7006297 · Received November 7, 2017

    Report

    Report Number
    7006297
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    August 2, 2017
    Report Date
    September 29, 2017
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFUSYSTEM AMBULATORY PUMP DID NOT INFUSE THE PROGRAMMED AMOUNT OF THE FLUOROURACIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787319 WALKMED AMBULATORY INFUSION PUMP PUMP, INFUSION FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPY