BEUDAMED
    FDA Adverse Event Death Summary report: N

    98XT

    MDR report key: 768364 · Received September 22, 2006

    Report

    Report Number
    768364
    Event Type
    Death
    Date Received
    September 22, 2006
    Date of Event
    September 8, 2006
    Report Date
    September 22, 2006
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IABP FAILED, THE BALLOON WOULD NOT FILL. AN AUTOFILL FAILURE WAS IDENTIFIED ON THE BALLOON PUMP. THE CHARGE NURSE ATTEMPTED TO TIGHTEN THE CONNECTIONS AND FILL THE IABP X3 WITHOUT SUCCESS. ANOTHER RN WENT TO GET ANOTHER IABP TO SWITCH IT OVER WHILE CHARGE RN WAS TRYING TO GET THE CURRENT ONE TO WORK. WITHIN SECONDS IT ALARMED V FIB/ V TACH. CPR WAS IMMEDIATELY STARTED. SECOND IABP HOOKED UP AND PUMPING THROUGHOUT THE CODE. PATIENT EXPIRED.THE PUMP WAS CHECKED BY OUR BIOMEDICAL SERVICES AND THE DRAIN PORT CONNECTION WAS COMPLETELY DISCONNECTED FROM THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 98XT IABP DSP DATASCOPE CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death