BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 975719 · Received January 4, 2007

    Report

    Report Number
    2087532-2007-00008
    Event Type
    Other
    Date Received
    January 4, 2007
    Date of Event
    December 6, 2006
    Report Date
    December 6, 2006
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PROBLEM WITH THE PRISMA MACHINE TAKING OFF TOO MUCH FLUID DURING A PT'S CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION. FACILITY'S INTENSIVE CARE NURSE HAD THE MACHINE PROGRAMMED TO REMOVE 210 ML/HOUR, HOWEVER FROM 1:00 AM TO 2:00 AM THE MACHINE INDICATED THAT THE FLUID REMOVAL WAS 406 ML. SHE PROGRAMMED THE MACHINE FOR ZERO FLUID REMOVAL, BUT NOTED IN THE NEXT HALF-HOUR THE MACHINE HAD ALREADY REMOVED 137 ML. THUS, THERE WAS AN EXCESSIVE FLUID REMOVAL OF 333 ML OVER A 1.5 HOUR TIME FRAME DURING A PT'S CRRT SESSION.

    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 68 YR Other