BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED®

    MDR report key: 8178317 · Received December 19, 2018

    Report

    Report Number
    8178317
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 29, 2018
    Report Date
    November 30, 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 STATES INFUSYSTEM PUMP WAS BEEPING AT 0130, CALLED THEIR 1-800 NUMBER AND WAS TOLD TO SHUT PUMP OFF AND CALL OUR CLINIC. PUMP WAS BEEPING ER.U, WHICH MEANS A PUMP MALFUNCTION. GAVE PATIENT A NEW PUMP, TREATMENT DELAYED 8.5 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018829 WALKMED® PUMP, INFUSION FRN WALKMED LLC 204609 00859695006077

    Patients

    Seq Age Sex Outcome Treatment
    1