BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 7770676 · Received August 9, 2018

    Report

    Report Number
    3000204189-2018-00006
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    April 12, 2016
    Report Date
    August 7, 2018
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF INTERNAL PROCESS IMPROVEMENT ACTIONS INITIATED AT WALKMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS PROGRAMMED TO DELIVER 20.8ML/HR INSTEAD OF DESIRED RATE OF 2.08ML/HR. ANTIDOTE OF 5FU WAS USED AND THE PATIENT WAS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610055 WALKMED WALKMED 350VL FRN WALKMED, LLC 350VL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other