BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCA PLUS II

    MDR report key: 35355 · Received July 1, 1996

    Report

    Report Number
    35355
    Event Type
    Death
    Date Received
    July 1, 1996
    Report Date
    July 1, 1996
    Manufacturer
    ABBOTT LAB
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE INCORRECTLY PROGRAMMED THE PUMP WHICH UNDERSTATED THE CONCENTRATION OF MEDICINE. THE PT SUBSEQUENTLY RECEIVED 10X THE PRESCRIBED MEDICINE AND WENT INTO RESPIRATORY ARREST. AFTER BEING COMATOSE FOR TWO WEEKS THE PT CEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA PLUS II PCA PUMP MEA ABBOTT LAB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death