BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1840849 · Received September 22, 2010

    Report

    Report Number
    6000001-2010-03430
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A LEAK. THE ROOT CAUSE WAS DETERMINED TO BE A RUPTURED RESERVOIR. THE DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA # IDC-CAPA-(B)(4). BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT DURING MANUFACTURING. TREND REVIEW DETERMINED THAT SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV 10 WAS LEAKING DURING FILLING. THE DEVICE WAS BEING FILLED WITH 230 MILLILITERS OF NORMAL SALINE WHEN THE LEAK WAS OBSERVED. 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 INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09K035

    Patients

    Seq Age Sex Outcome Treatment
    1