BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9616026-2006-00222

    MDR report key: 728445 · Received June 21, 2006

    Report

    Report Number
    9616026-2006-00222
    Event Type
    Malfunction
    Date Received
    June 21, 2006
    Product Code
    FII
    PMA / PMN Number
    k041005
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICAL COMPLAINT INVESTIGATION HAS BEEN PERFORMED. CRRT THERAPY WAS INITIATED FOR PT'S MEDICAL DIAGNOSIS OF MULTIPLE ORGAN FAILURE. THE CUSTOMER IS STATING THAT THE PT DEATH WAS NOT RELATED TO PRISMAFLEX SYSTEM. GAMBRO TECHNICAL SERVICES EVALUATED THE PRISMAFLEX SYSTEM. FUNCTIONALITY TEST PER MFR'S PROCEDURE AND A SIMULATED TREATMENT WAS PERFORMED. THE MACHINE, SCALES, PUMPS AND PRESSURE TESTED WITHIN MFR'S SPECIFICATIONS. 510(K)# IS K041005

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FII

    Patients

    Seq Age Sex Outcome Treatment
    1