BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCA II PUMP

    MDR report key: 348728 · Received August 22, 2001

    Report

    Report Number
    6000001-2001-00376
    Event Type
    Death
    Date Received
    August 22, 2001
    Date of Event
    July 24, 2001
    Report Date
    July 25, 2001
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PCAII PUMP WS REPORTED TO OVERINFUSE MORPHINE. THE PT HAD BEEN USING THIS PUMP FOR 4 DAYS PREVIOUS, IN THE CONTINUOUS MODE, AT A RATE OF 6 MG/HR, AND 8 MG/HR, AND 10MG/HR. IN 2001 AT 9:14PM, THE PUMP WAS PROGRAMMED AND STARTED IN THE BASAL/PCA MODE AS: CONCENTRATION 1 MG/ML, PCA DOSE 3.3 MG, DELAY 20 MINUTES, AND 1-HR. LIMIT 9.9 MG. THE PT DID NOT HAVE A PCA BUTTON. AT APPROX 10:15PM, THE PT EXPIRED (THE PT WAS A DNR PT). THE ORIGINAL REPORT WAS THAT 33.6 MG INFUSED IN 1 HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38444 PCA II PUMP ANESTHESIA PUMPS MEA BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death