BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD

    MDR report key: 11683638 · Received April 18, 2021

    Report

    Report Number
    3012307300-2021-03246
    Event Type
    Death
    Date Received
    April 18, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 19, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517096378
    PMA / PMN Number
    K111275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL CADD PUMPS WAS PROGRAMED PER THE NURSE PRACTITIONER'S ORDERS FOR CONTINUOUS INFUSION OF DILAUDID AND THE SETTINGS WERE VERIFIED BY 2 NURSES. THE INFUSION WAS STARTED AT 1228 AND CHECKED AT 1330. THE IV BAG WAS ALMOST EMPTY AND THE INFUSION WAS STOPPED. THE ORDER WAS CHECKED AND THE DRUG CONCENTRATION WAS VERIFIED. THE NURSE DETERMINED THAT THE DRUG CONCENTRATION WAS PROGRAMMED INCORRECTLY IN THE PUMP. THE PRIMARY AND SECONDARY NURSE ASSESSED THE PATIENT AND THE PHYSICIAN AND NURSE PRACTITIONER WERE SUMMONED. THE PATIENT WAS PRONOUNCED DEAD AT 1545. WE CONDUCTED SOME PERFORMANCE TESTING AND DETERMINED THAT THE PUMP WAS INFUSING TOO RAPIDLY. IT WAS INFUSING AT FOUR TIMES THE PROGRAMMED RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580946 CADD PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517096378

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death