BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS

    MDR report key: 2140192 · Received June 25, 2011

    Report

    Report Number
    6000001-2011-08879
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS OR A SAMPLE DEVICE WERE NOT PROVIDED, THEREFORE A BATCH REVIEW EVALUATION WERE NOT CONDUCTED. THE ROOT CAUSE OF THE DISCONNECTION WAS UNDETERMINED. A TREND REVIEW WAS CONDUCTED AND SIMILAR REPORTS HAVE BEEN RECEIVED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP REPORT SHALL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED VIA USER FACILITY MEDWATCH REPORT. THE CUSTOMER REPORTED THAT THE PATIENT WAS RECEIVING IV FLUIDS VIA CENTRAL LINE. THE PATIENT'S INTRAVENOUS (IV) INFUSION WAS DISCONTINUED AND A CLEARLINK LUER ACTIVATED VALVE WAS PLACED OVER THE LUMEN IN ORDER TO CAP THE LINE AND ASSIST THE PATIENT TO THE BATHROOM. THE PATIENT STOOD UP AND IMMEDIATELY EXHIBITED NEUROLOGICAL CHANGES. BLOOD WAS NOTICED AT THE CENTRAL LINE SITE AND THE DEVICE WAS NOTED DISCONNECTED FROM THE LUMEN. A CT SCAN WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R