BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURLIN MEDICAL

    MDR report key: 586502 · Received February 28, 2005

    Report

    Report Number
    MW1035025
    Event Type
    Injury
    Date Received
    February 28, 2005
    Date of Event
    February 9, 2005
    Report Date
    February 14, 2005
    Manufacturer
    *
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CALLED PHYSICIAN AT 5:30 PM TO SAY BAG WAS EMPTY. PT WAS HOOKED TO AMBULATORY PUMP WITH 4200 MG 5FU/135CC PROGRAMMED AT 2.9 CC/HR TO RUN OVES 46.33/HR. THIS WAS DOUBLE CHECKED BY 2 NURSES AND DOCUMENTED. PT RETURNED TO CLINIC THE NEXT DAY AT 8:15. BAG WAS EMPTY. PUMP SAID 140CC VOL AT 28.O CC/HR OVER 5 HOURS. PT WAS HOSPITALIZED THIS PAST WEEKENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN MEDICAL AMBULATORY PUMP FRN * 4000 106299

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening