BEUDAMED
    FDA Adverse Event Death Summary report: N

    CSF DRAINAGE KIT CONSISTS OF 10-110/10-450

    MDR report key: 500253 · Received December 11, 2003

    Report

    Report Number
    2028223-2003-00022
    Event Type
    Death
    Date Received
    December 11, 2003
    Report Date
    December 10, 2003
    Manufacturer
    CLINICAL NEURO SYSTEMS
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED. THE PATIENT PRESENTED TO THE HOSPITAL WITH AN INOPERABLE BRAIN TUMOR. THE SURGEON ATTACHED THE VENTRICULAR CATHETER TO THE CEREBROSPINAL FLUID COLLECTION DEVICE IN THE 10-111 KTI WITHOUT REMOVING THE RED END CAP. THIS RESULTED IN THE SYSTEM NOT DRAINING. SOMETINE LATER THE NURSE TREATING THIS PATIENT AT THE BESIDE NOTICED THE DEVICE WAS NOT DRAINING AND DISCONNECTED AT THE SITE. THIS RESULTED IN A RAPID FLOW OF CEREBROSPINAL FLUID, POTENTIALLY OVER DRAINING THE PATIENT. ONCE THE OVERDRAINAGE WAS UNDER CONTROL, THE SURGEON LEFT ORDERS TO DRAIN CEREBROSPINAL FLUID 6CM/H20. IT CAN NOT BE CONFIRMED, IF THESE SPECIFIC ORDERS WERE FOLLOWED. POSSIBLE TREATMENT INCLUDED 6CM/H20 BELOW THE FORAMEN OF MONROE IS MOST LIKELY WHAT THE NURSE MAY HAVE ADMINISTERED. THE PATIENT EXPIRED DUE TO BRAIN HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF DRAINAGE KIT CONSISTS OF 10-110/10-450 EXTERNAL VENTRICULAR DRAINAGE JXG CLINICAL NEURO SYSTEMS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death