BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1810361 · Received August 20, 2010

    Report

    Report Number
    6000001-2010-02677
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE ROOT CAUSE INVESTIGATION IS CURRENTLY BEING PERFORMED UNDER CAPA # (B)(4). 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 THREE INFUSOR LV 10 DEVICES WERE LEAKING DURING FREEZING. THIS IS REPORT NUMBER 1 OF 3. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10C007

    Patients

    Seq Age Sex Outcome Treatment
    1