BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK

    MDR report key: 1852888 · Received October 5, 2010

    Report

    Report Number
    6000001-2010-03744
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT DURING MANUFACTURING. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH IDC-CAPA-(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTEDLY AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INTERMATE LV 250 DEVICE RUPTURED DURING PATIENT USE. THE DEVICE HAD BEEN FILLED WITH 125 MILLILITERS OF SOLUTION WHEN THE RESERVOIR RUPTURED. THE RUPTURE CAUSED BLOOD TO BACKFLOW INTO THE TUBING OF THE DEVICE. 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 250, SINGLE-POUCH, 24 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10B005

    Patients

    Seq Age Sex Outcome Treatment
    1