BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 1770962 · Received July 27, 2010

    Report

    Report Number
    6000001-2010-01968
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INTERMATE LV5 WAS LEAKING DURING PATIENT USE. THE DEVICE WAS INFUSING AN UNKNOWN PATIENT WITH LIDOCAINE AND KETAMINE WHEN THE LEAK WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 5, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09J064

    Patients

    Seq Age Sex Outcome Treatment
    1