BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 611252 · Received June 3, 2005

    Report

    Report Number
    2921482-2005-00312
    Event Type
    Death
    Date Received
    June 3, 2005
    Date of Event
    May 10, 2005
    Report Date
    May 11, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A PT DEATH WHILE THE DEVICE WAS IN USE. IN 2005 AT UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED IN THE PCA ONLY MODE TO DELIVER MORPHINE 1MG/DL, WITH 1MG/ML, WITH A 1MG PCA DOSE, A 10 MINUTE PT LOCKOUT, AND A 25MG FOUR HOURS LIMIT. THE FOLLOWING DAY AT 2000, THE PT WAS REPORTEDLY "FOUND EXPIRED WHEN THE NURSE WENT IN TO CHECK ON THEM." THE PT WAS DEFIBRLLATED, AND TREATED WITH UNSPECIFIED DOSES OF "EPI AND BICARD." THE CUSTOMER CONTACT REPORTED THAT THE PT WAS "WORKED ON FOR 26 MINUTES" AND PRONOUNCED DEAF AT 2026. REPORTEDLY, "THE PCA HAS NOTHING TO DO WITH THE PT'S DEATH," AND THE DEVICE DELIVERED AS PROGRAMMED. THE CUSTOMER CONTACT REPORTED THAT IT IS BELIEVED THAT THE PT EXPIRED FROM A PULMONARY EMBOLISM. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death