BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 1831863 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03079
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. 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 LUER LOCK OF AN INFUSOR LV2 DEVICE BROKE WHILE ATTEMPTING TO DISCONNECT FROM A 3 WAY B. BRAUN STOPCOCK AFTER DELIVERING CARBOPLATINE TO AN UNKNOWN PATIENT. 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 INFUSOR LV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10C092

    Patients

    Seq Age Sex Outcome Treatment
    1