BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE GOLD

    MDR report key: 1419046 · Received July 11, 2009

    Report

    Report Number
    1419046
    Event Type
    Malfunction
    Date Received
    July 11, 2009
    Date of Event
    June 7, 2009
    Report Date
    July 12, 2009
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    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

    A CRITICALLY ILL, UNSTABLE PATIENT ON MULTIPLE INFUSIONS WAS BEING TRANSPORTED EMERGENTLY FOR A TEST/PROCEDURE. THE DOUBLE CHAMBER INFUSION PUMP FAILED MIDWAY DURING TRANSPORT. THE NURSE DISCONNECTED A NON-CRITICAL THERAPY FROM ANOTHER WORKING PUMP THAT WAS SAFE TO INFUSE VIA GRAVITY. THEN, THE WORKING PUMP WAS REPROGRAMMED TO INFUSE THE CRITICAL THERAPY FROM THE MALFUNCTIONING PUMP UNTIL A REPLACEMENT PUMPCOULD BE OBTAINED. THIS IS THE SECOND TIME THIS HAPPENED IN ONE DAY ON TWO DIFFERENT PUMPS. OUR BIOMEDICAL ENGINEERING DEPARTMENT FOUND THAT THE ALARIS INFUSION PUMP SUFFERED TWO "ENTIRE INSTRUMENT ILLEGAL RESETS." ACCORDING TO THE ALARIS TECH SUPPORT, THESE ERRORS ARE MICROPROCESSOR ERRORS AND THE INSTRUMENT IS IN NEED OF REPAIR. THE PUMP(S) WERE SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE GOLD INFUSION PUMP FRN ALARIS MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR