BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCA INFUSION PUMP

    MDR report key: 401693 · Received June 21, 2002

    Report

    Report Number
    401693
    Event Type
    Death
    Date Received
    June 21, 2002
    Date of Event
    June 13, 2002
    Report Date
    June 19, 2002
    Manufacturer
    ABBOTT LABORATORIES HPD
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNEXPECTED DEATH OF A PT DUE TO OVERDELIVERY OF DILAUDID (1MG/ML VERSUS 100 MCG/ML AS ORDERED), ONE BOLUS DOSE OF 0.5 ML INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA INFUSION PUMP INFUSION PUMP MEA ABBOTT LABORATORIES HPD 4100PLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Death