BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, 24 PACK,50126

    MDR report key: 1862008 · Received October 8, 2010

    Report

    Report Number
    6000001-2010-03861
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 8, 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 AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF SEPARATED TUBING. THE ROOT WAS DETERMINED TO BE A LACK OF SOLVENT AT THE CONNECTION BETWEEN THE TUBING AND THE STRESS-MEMBER. THIS DEVICE IS A SINGLE USE DEVICE AND WILL BE DISCARDED. BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO (B)(4) THAT THE TUBING OF AN INTERMATE LV 100 DEVICE SEPARATED FROM THE DEVICE BEFORE USE. DEVICE EVALUATION DETERMINED THAT THIS CONDITION WAS CAUSED BY A LACK OF SOLVENT AT THE CONNECTION BETWEEN THE TUBING AND THE STRESS-MEMBER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. 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