BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED®

    MDR report key: 8068512 · Received November 14, 2018

    Report

    Report Number
    8068512
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    August 23, 2018
    Report Date
    November 7, 2018
    Manufacturer
    WALKMED LLC
    Product Code
    FRN
    UDI-DI
    00859695006077
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED CLINIC TO INFORM NURSE THAT INFU SYSTEM PUMP WAS ALARMING AT HOME. PATIENT CAME TO CLINIC, PUMP SCREEN FLASHING 'ERR.U', ACCORDING TO MANUFACTURER TROUBLE SHOOTING GUIDE THIS IS A SYSTEM MALFUNCTION AND PUMP NEEDS TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910845 WALKMED® PUMP, INFUSION FRN WALKMED LLC 204609 00859695006077

    Patients

    Seq Age Sex Outcome Treatment
    1