BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIT PUMP CASSETTE

    MDR report key: 808216 · Received January 8, 2007

    Report

    Report Number
    1722214-2007-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2007
    Report Date
    December 8, 2006
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED A CASSETTE LEAKED SOME KIND OF CHEMO DRUG INTO THE PUMP. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENT ASSOCIATED WITH THIS MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *