BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 694087 · Received March 22, 2006

    Report

    Report Number
    9616240-2006-00250
    Event Type
    Malfunction
    Date Received
    March 22, 2006
    Date of Event
    January 19, 2006
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "THE PRISMA MACHINE REMOVED AT 03:00 1241 CC OF FLUID FROM PATIENT IN ONE HOUR. HOWEVER, THE PATIENT'S WEIGHT ACTUALLY UP 2.1 KG FROM THE MORNING BEFORE. THE PRISMA MACHINE WAS RE-CALIBRATED. THE TYPE OF PATIENT'S INTERVENTION WAS NOT SPECIFIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention