BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED®

    MDR report key: 8109908 · Received November 28, 2018

    Report

    Report Number
    8109908
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    August 10, 2018
    Report Date
    November 6, 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 INTO THE CLINIC AFTER NOT BEING ABLE TO TROUBLE SHOOT THE ISSUE OF HIS HOME INFUSION PUMP EVEN AFTER CALLING THE 800 NUMBER ON THE PUMP. UPON ARRIVAL, THE PUMP WAS NOT INFUSING AND HAD DELETED THE SET PROGRAM. A NEW PUMP WAS ISSUED AND PATIENT CONTINUED WITH HIS INFUSION. INTERRUPTION OF INFUSION LASTED APPROX. 1 1/2 HOURS. MD MADE AWARE- NO HARM TOWARDS PATIENT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949451 WALKMED® PUMP, INFUSION FRN WALKMED, LLC 204609 00859695006077

    Patients

    Seq Age Sex Outcome Treatment
    1