BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 980167 · Received February 28, 2007

    Report

    Report Number
    2087532-2007-00057
    Event Type
    Other
    Date Received
    February 28, 2007
    Date of Event
    January 8, 2007
    Report Date
    January 29, 2007
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IN THE MEDWATCH: "AT 06:20, CVVHD MACHINE STOPPED WORKING AND SHOWS "PUMP MALFUNCTION". RN TRIED TO TROUBLESHOOT AND CONTINUED WITH TREATMENT. AT 06:40, SAME MESSAGE SHOWED UP AND RN STOPPED TREATMENT ACCORDING TO INSTRUCTION ON SCREEN AND CALLED DIALYSIS RN. THE MACHINE WAS REMOVED FROM SERVICE RIGHT AWAY. NO DELAY IN TREATMENT OR ANY HARM TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA CONTROL UNIT INTENSIVE CARE HEMODIALYSIS FII GAMBRO DASCO PRISMA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other