BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK

    MDR report key: 1831871 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03083
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A RUPTURED RESERVOIR. 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. 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 THE RESERVOIRS OF TWO INTERMATE LV250 DEVICES RUPTURED DURING PATIENT USE. THIS IS REPORT NUMBER 1 OF 2. THE DEVICES WERE INFUSING THE PATIENT WITH FORTUM WHEN THE RESERVOIRS RUPTURED. 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 INTERMATE LV 250, SINGLE-POUCH, 24 PACK PUMP, INFUSION MEB BAXTER HEALTHCARE - IRVINE 10C042

    Patients

    Seq Age Sex Outcome Treatment
    1