BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ

    MDR report key: 1251390 · Received November 26, 2008

    Report

    Report Number
    1251390
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 25, 2008
    Report Date
    November 26, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    THE PUMP WAS POWERED ON TO BEGIN AN INFUSION. BEFORE THE DEVICE COULD BE PROGRAMMED, THE PUMP ALARMED WITH SEVERAL MALFUNCTIONS: S308, S408, POST SW ALARM CODE 65539, POST SW ALARM CODE 65559, AND THE USUAL S321 MALFUNCTION. THE ALARMS WERE ACKNOWLEDGED AND THE PUMP WAS POWERED DOWN AND SEQUESTERED. THERAPY WAS STARTED ON A DIFFERENT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ INFUSION PUMP FRN HOSPIRA GLOBAL MEDICAL AFFAIRS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *