BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED®

    MDR report key: 8178326 · Received December 19, 2018

    Report

    Report Number
    8178326
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 14, 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 INFORMED NURSE INFUSION PUMP WAS OFF AT 0145 WHICH WAS NOTICED BY THE RN WHO ARRIVED AT HER HOUSE FOR 5FU INFUSION DISCONNECT. THE PATIENT DID NOT HEAR ANY ALARMS. NURSING PLACEMENT REPLACED BATTERY AND PUMP STARTED RUNNING. THE PATIENT HAD 18 HRS LEFT TO INFUSE. HE RETURNED TO PATIENT'S HOUSE THE NEXT MORNING AND DISCONNECTED PUMP WHEN 5FU HAD FINISHED INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019132 WALKMED® PUMP, INFUSION FRN WALKMED LLC 204609 00859695006077

    Patients

    Seq Age Sex Outcome Treatment
    1