BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLUCERNA

    MDR report key: 2395073 · Received December 7, 2011

    Report

    Report Number
    2395073
    Event Type
    Death
    Date Received
    December 7, 2011
    Date of Event
    September 24, 2011
    Report Date
    November 30, 2011
    Product Code
    KPE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ORDERED TPN (TOTAL PARENTERAL NUTRITION). RN OBTAINED GLUCERNA ENTERAL FEEDING FROM PANTRY. RN OBTAINED IV TUBING FROM OMNI CELL AND ATTACHED TUBING BY SPIKING THE BOTTLE. THE IV TUBING WAS CONNECTED TO THE PICC IV LINE AND INFUSED VIA A VEIN. THE PATIENT CODED AND DIED. THE WARNINGS ON THE BOTTLE ARE NOT ADEQUATE (EMBOSSING NOT CLEARLY VISIBLE AND FONT VERY SMALL THAT SAYS "NOT FOR IV USE". THE LABEL COMES OFF. THE BOTTLE ALLOWED FOR SPIKING. THE MANUFACTURER WAS IMMEDIATELY NOTIFIED ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCERNA ENTERAL FEEDING KPE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death