BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMA M-100 PRE-SET FILTERS

    MDR report key: 1740980 · Received June 11, 2010

    Report

    Report Number
    1740980
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 17, 2010
    Report Date
    June 11, 2010
    Manufacturer
    GAMBRO
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT PRESENTED WITH ACUTE RENAL FAILURE, TACHYPNIC, RESTLESSNESS AND WAS CONFUSED. CONTINUOUS VENOVENOUS HEMODIAFILTRATION (CVVHDF) WAS STARTED THEN DOPAMINE WAS STARTED AT 5MCG/KG/MIN FOR LOW BP. THE BP CONTINUED TO DROP SO THE LEVOPHED AND DOPAMINE WERE INCREASED. TWENTY MINUTES LATER, THE BP DID NOT IMPROVE AND THE HEART RATE STARTED SLOWING. A CODE BLUE WAS CALLED. THE PT HAD NO PULSE AND CPR WAS STARTED. THE CVVHDF FILTER WAS CLOTTED. THE STAFF WAS UNABLE TO RESUSCITATE THE PT. THE PT WAS PRONOUNCED FIFTEEN MINUTES AFTER THE CODE BLUE WAS CALLED. PRIOR TO THIS EVENT THE MACHINE WAS CHANGED. FIVE FILTERS FROM THIS LOT WERE USED IN THE FIRST MACHINE BEFORE IT WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA M-100 PRE-SET FILTERS FILTER, BLOOD, DIALYSIS, CVVHDF FKJ GAMBRO AN69HF N-100 09J2167G

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death