BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCUDRAIN

    MDR report key: 4124661 · Received August 21, 2014

    Report

    Report Number
    4124661
    Event Type
    Death
    Date Received
    August 21, 2014
    Date of Event
    September 23, 2013
    Report Date
    August 21, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT NOTED TO HAVE HIGH ICP TO 30'S, NEURO EXAM DETERIORATED. NEUROSURGERY NOTIFIED AND WENT IN TO ASSESS PT. STAT CT DONE. OR SCHEDULED FOR URGENT DECOMPRESSION. FAMILY CALLED IN URGENTLY.WHEN ATTEMPTING TO TRANSDUCE ICP TO SHOW THE TECHNIQUE TO ANESTHESIA, WHO WAS PRESENT TO PICK UP PATIENT FOR OR, NOTICED SLACK AT STOPCOCK OF VENTRICULOSTOMY DRAIN SET (#1) AND NOTICED CRACK WITH TUBING COMPLETELY BREAKING OFF STOPCOCK ON INSPECTION-LEAVING VENT DRAIN OPEN TO AIR AT PATIENT SIDE. DRAIN IMMEDIATELY CLAMPED AND COVERED W/STERILE DRESSING AND SYSTEM REPLACED WITH NEW SET UP, INCLUDING NEW TRANSDUCER.ICP READING WITH NEW SET UP WAS 28 INITIALLY, THEN LOWERED TO 2-3. OR CANCELLED BY NEUROSURGERY DUE TO LOW READINGS. UPON CLOSE INSPECTION, HOWEVER, NOTED SMALL CRACK AT STOPCOCK OF NEW SET (#2) WITH SIGNIFICANT LEAKING OF CSF.VENT DRAIN CLAMPED IMMEDIATELY AND ANOTHER NEW DRAIN SET UP INCLUDING NEW TRANSDUCER WAS PLACED. ICP READINGS 28-30.OR RESCHEDULED FOR URGENT BRAIN DECOMPRESSION. PATIENT LEFT FOR OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504996 ACCUDRAIN SHUNT JXG INTEGRA LIFESCIENCES CORP. * 1130155
    505123 ACCUDRAIN SHUNT JXG IINTEGRA LIFESCIENCES CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death INTRACRANIAL PRESSURE WAS BEING MONITORED VIA AN| OTHER| EDWARDS TRANSDUCER SET