BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 10477835 · Received September 1, 2020

    Report

    Report Number
    3000204189-2020-00004
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 20, 2020
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER MW5095491, "PUMP WAS PROGRAMMED WRONG IN THE WALKMED PUMP. DECIMAL POINT LOCATION VARIES FROM PUMP TO PUMP. RATE WAS ENTERED AS 20MG/HR INSTEAD OF 2ML/HR. PATIENT WAS ADMITTED TO HOSPITAL, VISTOCARD X 20 DOSES GIVEN TO PATIENT". NO CONTACT INFORMATION OR SERIAL NUMBER WAS GIVEN. PUMP WAS DESIGNED TO ALLOW THE MOVEMENT OF THE DECIMAL PLACE BASED ON DESIRED RESOLUTION OF INFUSION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943812 WALKMED WALKMED 350VL FRN WALKMED, LLC 350VL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization