BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 1823199 · Received September 1, 2010

    Report

    Report Number
    6000001-2010-02954
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF TUBING DETACHED COMPLETELY FROM THE STRESS-MEMBER. THE ROOT CAUSE OF THIS CONDITION IS CURRENTLY INVESTIGATION BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT DURING MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE BLUE WINGED LUER CAP OF THREE INTERMATE LV100 DEVICES WERE FOUND TO BE DETACHED. THIS IS REPORT NUMBER 2 OF 3. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 100, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10B037

    Patients

    Seq Age Sex Outcome Treatment
    1