BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA WITH MEDNET

    MDR report key: 1270120 · Received December 17, 2008

    Report

    Report Number
    2921482-2008-00420
    Event Type
    Death
    Date Received
    December 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    November 10, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING WHICH RESULTED IN AN ADVERSE EVENT WHILE THE DEVICE WAS IN CLINICAL USE. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER DILAUDID 1MG/ML. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PHYSICIAN ORDERED THE PATIENT TO RECEIVE DILAUDID 5MG/ML. AT AN UNSPECIFIED TIME, A NEW VIAL WAS LOADED INTO THE PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE ENTERED THE PATIENT'S ROOM AND FOUND THE PATIENT WAS NOT BREATHING. IT WAS REPORTED THE PATIENT HAD EXPIRED. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. IT WAS REPORTED THAT AFTER A REVIEW OF THE PUMP HISTORY BY THE USER FACILITY, IT WAS DETERMINED THAT THE DEVICE WAS PROGRAMMED TO DELIVER A CONCENTRATION OF 1MG/ML INSTEAD OF THE INTENDED CONCENTRATION OF 5MG/ML. THOUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA WITH MEDNET MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death DILAUDID