BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA 3

    MDR report key: 601054 · Received May 9, 2005

    Report

    Report Number
    2921482-2005-00267
    Event Type
    Death
    Date Received
    May 9, 2005
    Date of Event
    March 25, 2005
    Report Date
    April 19, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIEVED OF A DEATH WHILE DEVICE WS IN CLINICAL USE. THE CUSTOMER CONTACT REPORTED THAT ON AN UNSPECIFIED DATE THE DEVICE WAS PROGRAMMD IN THE CONTINUOUS MODE TO DELIVER AN UNSPECIFIED CONCENTRATION OF MORPHINE AT AN UNSPECIFIED RATE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT REPORTEDLY EXPIRED FOLLOWING AN UNSUCCESSFUL RESUSCITATION. THE PATIENT HAD REPORTEDLY RECEIVED A TOTAL OF 36MG IN TWELVE HOURS. THE CAUSE OF DEATH WAS REPORTED AS AN "ASPIRATION". IT IS UNSPECFIED WHETHER AN AUTOPSY WAS PERFORMED. THE CUSTOMER CONTACT INDICATED, "THERE IS NO SUGGESTION THAT THE DRUG OR THE PUMP WERE INVOLVED IN THE EVENT OR DEATH." THE CUSTOMER REPORTED THAT THE EVENT WAS NOT RELATED TO THE "PROGRAMMING OR THE USE OF THE PUMP." THOUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA 3 PCA INFUSION PUMP MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death