BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE GOLD

    MDR report key: 2800792 · Received September 26, 2012

    Report

    Report Number
    2800792
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    June 6, 2012
    Report Date
    September 26, 2012
    Manufacturer
    CAREFUSION 303, INC.
    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

    PATIENT WITH IFOSFAMIDE (MEDICATION) INFUSING WHEN PUMP MALFUNCTIONED. INFUSION CHANGED TO NEW PUMP AND FINISHED WITHOUT INCIDENT. FURTHER INVESTIGATION DETERMINED THE PUMP WAS PROGRAMMED CORRECTLY BUT PRESSURE CALIBRATION WAS REQUIRED. CLINICAL ENGINEERING WAS ABLE TO CALIBRATE AND RUN INFUSIONS WITH THE PUMP POST INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE GOLD PUMP, INFUSION FRN CAREFUSION 303, INC. 7130.00 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR