BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED

    MDR report key: 6376028 · Received March 3, 2017

    Report

    Report Number
    6376028
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 14, 2017
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS INVOLVES A WALKMED 350VL: PATIENT CAME TO CLINIC AT APPROXIMATELY 9:45AM STATING "MY PUMP ISN'T RUNNING". OBSERVED THAT PUMP WINDOW (SCREEN) WAS COMPLETELY BLANK AND NO INDICATOR LIGHT WAS BLINKING. CHECKED BATTERY AND IT WAS SECURELY ATTACHED. PATIENT STATES, "I DIDN'T TOUCH ANYTHING" AND "THAT COVER IS ALWAYS ON IT." TURNED PUMP BACK ON BY PUSHING POWER BUTTON AND THE WINDOW (SCREEN) CAME ON AND THE SETTING REVEALED 2.39 ML/HR, 2.45 ML DELIVERED, 110ML MAX VOLUME TO DELIVER, AND UNL TO INDICATE PUMP BUTTONS ARE LOCKED. BAG HOLDING THE 5FU IS OBSERVED TO BE VERY FULL. THE UNIT WAS COMPLETELY POWERED OFF. MANUFACTURER RESPONSE FOR WALK MED INFUSION PUMP, WALKMED350VL (PER SITE REPORTER). WALK MED PUMP CONTRACTOR TO PICK UP AND EVALUATE THE PUMP THAT MALFUNCTIONED. PATIENT GIVEN NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159936 WALKMED PUMP, INFUSION FRN WALKMED, LLC WALKMED 350VL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR