BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRIX

    MDR report key: 47122 · Received October 29, 1996

    Report

    Report Number
    47122
    Event Type
    Death
    Date Received
    October 29, 1996
    Date of Event
    October 22, 1996
    Report Date
    October 29, 1996
    Manufacturer
    NEURO CARE, INC.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 44-YR-OLD PT UNDERWENT CRANIOTOMY TO REMOVE 4CM TUMOR. VENTRICULAR CATH PLACED AND ATTACHED TO DRAINAGE SYSTEM. STOP COCK AND CLAMPS OPENED IN RECOVERY ROOM, TO DEPENDANT DRAINAGE WITH 100CC OUTPUT. TRANSFER TO ICU - NEUROLOGICALLY RESPONSIVE, ALERT, COOPERATIVE X 7.5 HRS. ABRUPTLY BECAME OBTUNDED. WHILE IN THE RADIOLOGY DEPT THE CLAMP ON THE DRIP CHAMBER VENT WAS DISCOVERED TO BE CLOSED. PT IS NOT EXPECTED TO RECOVER - BRAIN DEATH TO BE DOCUMENTED. RISK MGR UNABLE TO DETERMINE WHO/HOW CLAMP WAS CLOSED. NURSES REQUEST PRODUCT CHANGE TO MAKE VENT CLAMP A DIFFERENT COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRIX VENTRICULAR DRAINAGE SYSTEM GWM NEURO CARE, INC. NL 850-500V *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death| L| R VETRICULAR CATHETER