BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOGARD 6300

    MDR report key: 241448 · Received September 16, 1999

    Report

    Report Number
    241448
    Event Type
    Injury
    Date Received
    September 16, 1999
    Date of Event
    August 11, 1999
    Report Date
    September 2, 1999
    Manufacturer
    BAXTER HEALTHCARE QUALITY MGMT
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT DECOMPRESSION LAMINECTOMY OF T9-T10 FOR EXTRADURAL THORACIC CORD COMPRESSION SECONDARY TO ARTERIOVENOUS MALFORMATION. POST-OPERATIVELY THE PT WAS NOTED TO HAVE RIGHT LEG WEAKNESS AND NUMBNESS. THE PT WAS STARTED ON METHYLPREDNISOLONE, PER ACUTE SPINAL CORD INJURY PROTOCOL. THE PT WAS TO RECEIVE A BOLUS OF METHYLPREDNISOLONE, THEN AN INFUSION OF 5.4MG/KG X 23 HOURS. THE DRUG WAS TO INFUSE AT 20CC/HR. THE INFUSION WAS INITIATED AT 11:00 A.M. AT 2:00 A.M. IT WAS DISCOVERED THAT THE PUMP WAS NOT INFUSING THE MEDICATION; THE PT HAD NOT RECEIVED THE METHYLPREDNISOLONE. THE PT CONTINUES TO HAVE RIGHT LOWER EXTREMITY WEAKNESS AND NUMBNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD 6300 INFUSION PUMP FRN BAXTER HEALTHCARE QUALITY MGMT 2M8048 *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| S