BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMA CONTROL CARE

    MDR report key: 667163 · Received January 24, 2006

    Report

    Report Number
    9616240-2006-00018
    Event Type
    Injury
    Date Received
    January 24, 2006
    Date of Event
    December 29, 2004
    Report Date
    January 10, 2005
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    Removal / Correction Number
    Z-1545-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MACHINE REMOVED TOO MUCH FLUID. THE REQUESTED REMOVAL RATE WAS SET AT 25-50CC/HR AND A FLUID REMOVAL PROBLEM WAS NOTICED AT APPROX AT 05:00 PM. THE TREATMENT HISTORY SHOWED THAT THE FLUID REMOVAL RATE WAS SET TO 150ML/HR AT 12:50 PM AND IT WAS DECREASED TO 100ML/HR AT 16:28 PM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening