BEUDAMED
    FDA Adverse Event Death Summary report: N

    9616026-2008-00013

    MDR report key: 1150323 · Received September 3, 2008

    Report

    Report Number
    9616026-2008-00013
    Event Type
    Death
    Date Received
    September 3, 2008
    Product Code
    MQS
    PMA / PMN Number
    K072093
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMAFLEX MACHINE IN USE AT THE TIME OF THE REPORTED EVENT HAS BEEN USED AFTER THE REPORTED EVENT WITH NO PROBLEMS. A GAMBRO REP HAS NOT INSPECTED THE PRISMALFLEX MACHINE, SINCE THERE WERE NO REPORTED PROBLEMS, PRIOR TO THE DECISION TO TERMINATE TREATMENT. IT IS A GAMBRO POLICY, THAT ALL DEATHS OCCURRING DURING OR WITHIN 24 HOURS AFTER TREATMENT, REGARDLESS OF CAUSE, SHALL BE REPORTED. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ITS DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1