BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK

    MDR report key: 1942634 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06403
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. A TREND REVIEW HAS BEEN CONDUCTED AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED. THE ROOT CAUSE IS CURRENTLY UNDER INVESTIGATION THROUGH (B)(4). 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 INFUSOR LV 5 DEVICE RUPTURED DURING PATIENT USE. THE DEVICE WAS ADMINISTERING MERONEM IN 250 MILLILITERS NACL TO THE PATIENT WHEN THE RESERVOIR RUPTURED. 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 10F050

    Patients

    Seq Age Sex Outcome Treatment
    1 MENOREM| NACL