BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE GOLD

    MDR report key: 2800925 · Received September 27, 2012

    Report

    Report Number
    2800925
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN OPERATING INFUSION PUMP WHEN IT BEGAN MAKING ODD NOISES AND ALARMING "HIGH PRESSURE". PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) FLUSHED WITHOUT DIFFICULTY AND WHEN SWITCHED TO ANOTHER PUMP, NO ISSUES WERE NOTED. ORIGINAL PUMP WAS SECURED FOR REVIEW BY CLINICAL ENGINEERING. UPON FURTHER INVESTIGATION BY CLINICAL ENGINEERING, IT WAS DISCOVERED A FAN WAS BROKEN WITHIN THE PUMP CAUSING THE GRINDING NOISE. FAN WAS REPLACED AND PUMP APPEARED TO WORK NORMALLY GOING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE GOLD PUMP, INFUSION FRN ALARIS MEDICAL SYSTEMS 7230 *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR