BEUDAMED
    FDA Adverse Event Death Summary report: N

    HICKMAN HEMODIALYSIS/PLASMAPHERESIS CATHETER

    MDR report key: 32417 · Received April 30, 1996

    Report

    Report Number
    32417
    Event Type
    Death
    Date Received
    April 30, 1996
    Date of Event
    March 26, 1996
    Report Date
    April 12, 1996
    Manufacturer
    BARD ACCESS SYSTEM, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A CARDIAC ARREST IN THE OR AT THE COMPLETION OF PLACEMENT OF THE PLASMA APHERESIS CATHETER. SHE WAS UNABLE TO BE RESUSCITATED AND EXPIRED. THE AUTOPSY REVEALED A SMALL PERFORATION OF THE CORONARY SINUS WITH HEMOPERICARDIUM WHICH MAY HAVE BEEN FROM THE CATHETER GUIDE WIRE OR TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN HEMODIALYSIS/PLASMAPHERESIS CATHETER Implant ROUND DUAL LUMEN HEMODIALYSIS/PLASMAPHERESIS CATHETER DQO BARD ACCESS SYSTEM, INC. 13.5FR, 28CM 36CE7814

    Patients

    Seq Age Sex Outcome Treatment
    1 4.5 YR Death