BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 6867258 · Received September 14, 2017

    Report

    Report Number
    1723533-2017-00016
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    September 2, 2017
    Report Date
    September 14, 2017
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S WIFE CALLED STATING THE PUMP WAS BEEPING AND SAYING "END". THE INFUSION WAS COMPLETED IN APPROXIMATELY 72 HOURS INSTEAD OF 168 HOURS PER THE PATIENT'S WIFE. ACCORDING TO THE PATIENT'S WIFE, THERE WAS NO PATIENT INJURY WHICH WAS CONFIRMED BY THE DOCTORS OFFICE IN A CALL. THE PUMP WAS REPORTEDLY PROGRAMMED TO INFUSE 2ML PER HOUR. WALKMED FOLLOWED THE EVENT WITH A CALL TO THE DOCTOR'S OFFICE. THE NURSE STATED THE PUMP WAS PROGRAMMED IMPROPERLY AND THERE WAS NO PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647404 WALKMED INFUSION PUMP FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other