BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1056072 · Received May 23, 2008

    Report

    Report Number
    2016493-2008-00043
    Event Type
    Other
    Date Received
    May 23, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 29, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RECEIVED A COPY OF CUSTOMERS MEDWATCH FORM. EVENT DESCRIPTION LISTED ON THE MEDWATCH FORM AS INFUSING FASTER THAN INTENDED RATE. PUMP WAS TURNED OFF, FLUIDS CONTINUED TO INFUSE. PT WAS STABLE. CUSTOMER DOES NOT WANT THEIR NAME OR IDENTITY RELEASED TO CARDINAL HEALTH. CUSTOMER DECLINED TO SEND DEVICE TO CARDINAL HEALTH FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION SYSTEM FRN, INFUSION SYSTEM FRN CARDINAL HEALTH ALARIS PRODUCTS 1325D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other