BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 1629794 · Received March 2, 2010

    Report

    Report Number
    1629794
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Date of Event
    August 17, 2009
    Report Date
    March 2, 2010
    Manufacturer
    GAMBRO AMERICAN
    Product Code
    MQS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE CRRT MACHINE WAS IN USE ON THE PT. THERE WAS NO BLOOD PUMPING FROM THE PT AND CITRATE FILLED HALF OF THE FILTER. THE MACHINE WAS STOPPED AND THE DIALYSIS CATHETER WAS FLUSHED. THE HEAD NURSE RESTARTED THE MACHINE AND IT WAS DETERMINED THAT THERE WAS A MACHINE MALFUNCTION. THE MALFUNCTION OCCURRED FOUR HOURS AFTER THE CRRT WAS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA HEMODIALYSIS, CRRT MQS GAMBRO AMERICAN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR