BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 7696363 · Received July 17, 2018

    Report

    Report Number
    3000204189-2018-00005
    Event Type
    Injury
    Date Received
    July 17, 2018
    Date of Event
    May 21, 2018
    Report Date
    July 16, 2018
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT INITIALLY CALLED THE MANUFACTURER'S HOTLINE TO SAY HIS PUMP WAS NOT RUNNING AND THAT THE BAG WAS EMPTY. THE HOTLINE OPERATOR INSTRUCTED THE PATIENT TO REPLACE THE BATTERY. AFTER THE BATTERY WAS REPLACED, THE PUMP WOULD NOT RUN. IT APPEARS TO WALKMED THAT THE PUMP WAS NOT RUNNING BECAUSE IT WAS DONE INFUSING. UPON FURTHER REVIEW BY THE CLINIC, THE PUMP WAS SET AT 20.7ML/HR WITH THE INTENDED INFUSION RATE OF 2.07ML/HR. PATIENT RECEIVED ANTIDOTE, LABS AND EKG. NURSE NOTED THE PATIENT DID NOT EXPERIENCE ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536441 WALKMED 350VL FRN WALKMED, LLC 350VL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention