BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS GOLD SIGNATURE

    MDR report key: 1273928 · Received December 14, 2008

    Report

    Report Number
    1273928
    Event Type
    Malfunction
    Date Received
    December 14, 2008
    Date of Event
    November 18, 2008
    Report Date
    December 14, 2008
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT TRANSPORTED TO CT SCAN WITH AN ALARIS PUMP INFUSING ZANTAC IV. APPROXIMATELY 45 MINUTES LATER, THE PATIENT RETURNED TO THE FLOOR. THE PATIENT'S PUMP WAS NO LONGER ON, AND THE TRANSPORTER STATED THAT IT WAS NO LONGER WORKING AND TO CALL CT WITH QUESTIONS. WHEN THE PUMP WAS TURNED ON, IT BEGAN TO ALARM "INSTALLATION MALFUNCTION." ATTEMPTED TO TURN IT OFF AND THEN ON AGAIN, BUT STILL IT WAS ALARMING INSTALLATION MALFUNCTION. UN-PLUGGED THE UNIT FROM OUTLET, AND SECURED ANOTHER ALARIS PUMP TO CONTINUE THE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS GOLD SIGNATURE PUMP, INFUSION FRN CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES 7130 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR