BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ

    MDR report key: 1233304 · Received November 10, 2008

    Report

    Report Number
    1233304
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 10, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS, DIRECTOR GLOBAL COMPLAINT MANAGER
    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. AFTER THE INITIAL BOOT UP, THE EQUIPMENT ALARMED WITH MALFUNCTION S421 MOTOR ERROR, SUBGROUP 20, PUMP PLUNGER HOMING TIMEOUT, URGENCY HIGH, ALARM ID: 132. GENERIC ARG1: 822, ARG2-4:0. THE ALARM WAS SILENCED AND THE DEVICE WAS FORCED INTO SHUTDOWN. THE MEDICATIONS WERE REMOVED AND RESTARTED ON A DIFFERENT PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *