BEUDAMED
    FDA Adverse Event Death Summary report: N

    BM II

    MDR report key: 36762 · Received August 12, 1996

    Report

    Report Number
    36762
    Event Type
    Death
    Date Received
    August 12, 1996
    Date of Event
    July 30, 1996
    Report Date
    August 8, 1996
    Manufacturer
    RENAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 3 Y/O WITH COMPLEX CONGENITAL CARDIAC DISEASE UNDERWENT A FONTAN PROCEDURE ON 7/15/96. DEVELOPED RENAL FAILURE S/P SURGERY AND REQUIRED CVVH. ON 7/29/96 AT 7:45 PM PRESSURE ALARMS CONTINUED TO ALARM, AND AT 8:40 PM, CO'S 800# FOR TECHNICAL ASSISTANCE WAS ACCESSED. STAFF ADVISED TO REMOVE UNIT. OTHER UNIT IS WITH CO SINCE APRIL FOR REPAIRS. AT 3:53 AM ON 7/30, PT PRONOUNCED, HAD VENTRICULAR DYSRHYTHMIAS REFRACTORY TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BM II HEMOFILTRATION UNIT FII RENAL DIV. BAXTER HEALTHCARE CORP. 5M 3005R *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death