BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT INTERMITTENT PUMP

    MDR report key: 617521 · Received August 6, 2004

    Report

    Report Number
    1722214-2004-00014
    Event Type
    Malfunction
    Date Received
    August 6, 2004
    Report Date
    July 8, 2004
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFUSION WAS INCOMPLETE. THERE WAS EXCESS SOLUTION LEFT OVER IN THE MEDIBAG. THE LEFTOVER SOLUTION WAS ESTIMATED TO BE APPROXIMATTLY 20-30 ML'S. THE INFUSION PUMP HAD A SHORTER THAN EXPECTED DOSE TIME. THERE WERE NO REPORTS THAN EXPECTED DOSE TIME. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS ASSOCIATED WITH THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIT INTERMITTENT PUMP AMBULATORY INFUSION PUMP FRN SORENSON MEDICAL, INC. INTERMITTENT 311078

    Patients

    Seq Age Sex Outcome Treatment
    1 *