BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK

    MDR report key: 1813485 · Received August 24, 2010

    Report

    Report Number
    6000001-2010-02726
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DISCARDED THE DEVICE. THEREFORE, THE REPORTED CONDITION OF A LEAK DUE TO THE DEVICE'S LUER BECOMING DETACHED FROM THE TUBING COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. A TREND REVIEW WAS PERFORMED SHOWING A FAVORABLE TREND YEAR OVER YEAR FOR REPORTED COMPLAINTS OF SEPARATED COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INTERMATE LV 250 DEVICE LEAKED AFTER THE DEVICE'S LUER BECAME DETACHED FROM THE TUBING. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THIS CONDITION OCCURRED DURING AN INFUSION OF MEROPENEM ON A MALE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 09N054

    Patients

    Seq Age Sex Outcome Treatment
    1