BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION

    MDR report key: 1192386 · Received October 6, 2008

    Report

    Report Number
    9616066-2008-00032
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 8, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE STARTED A POTASSIUM INFUSION 10 MEQ/100ML AS A SECONDARY TO RUN AT 100 ML/HR. THE SECONDARY WAS COMPLETED IN 15 MINUTES. THE NURSE NOTED FLUID BACKING UP INTO THE PRIMARY SET 2420-0500. THE RESIDENT ORDERED THE PT BE ON TELEMETRY AND 3 GRAMS OF CALCIUM GLUCONATE GIVEN. PT HAD NO SEQUELA. INVESTIGATION ONGOING. FOLLOW UP WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION FPA SET, ADMINISTRATION FPA CARDINAL HEALTH ALARIS PRODUCTS 2420-0500 08055888

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention