BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT PUMP CASSETE

    MDR report key: 599345 · Received April 28, 2005

    Report

    Report Number
    1722214-2005-00005
    Event Type
    Malfunction
    Date Received
    April 28, 2005
    Report Date
    April 4, 2005
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE SCRUB TECH IN SURGERY HOOKED THE LONG LINE OF THE AMBIT CASSETTE TO THE MEDIBAG AND THE SHORT LINE TO THE WOUND CATHETER. THE PT REPORTED TO THE DISTRIBUTOR THAT THERE WAS BLOOD BACKED UP INTO THE MEDIBAG. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS ASSOCIATED WITH THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIT PUMP CASSETE AMBULATORY INFUSION PUMP CASSETTE FRN SORENSON MEDICAL, INC. NA 308102

    Patients

    Seq Age Sex Outcome Treatment
    1 *