BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1013344 · Received March 13, 2008

    Report

    Report Number
    2016493-2008-00014
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 14, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO REQUESTED AND ALL AVAILBLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    RISK MGR REPORTED 250ML BAG OF DOPAMINE INFUSED IN 2 HRS. 400MG DOPAMINE IN 250ML OF SOLUTION HUNG AT ABOUT 8:15PM AND COMPLETELY INFUSED BY 10:25PM. THE B/P AND HEART RATE ELEVATED. PT REQUIRED INCREASED MONITORING OF VITAL SIGNS AND CARDIAC ENZYMES WERE ORDERED. BY 2/12 THE VITAL SIGNS RETURNED TO NORMAL. SHE DID NOTE PT MIGHT NOT SURVIVE THIS HOSPITALIZATION, BUT DOES NOT FEEL THAT PUMP INCIDENT WOULD MAKE ANY DIFFERENCE. PT EXPIRED A FEW DAYS LATER. EVENT LOG REVIEW DETERMINED FOUR CHANNELS INFUSING DIFFERENT MEDICATIONS AT THE TIME OF EVENT. THE CHANNEL CONTAINING THE DOPAMINE INFUSION WAS PROGRAMMED CORRECTLY. RATE ACCURACY AND PRESSURE TESTING FOUND DEVICES TO BE OPERATING WITHIN SPECS. THE OCCLUDER SPRINGS WERE INSPECTED AND FOUND IN PROPER OPERATING CONDITION. NO ANOMALIES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION SYSTEM FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention