BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITORR CSF EXTERNAL DRAINAGE SYST

    MDR report key: 6864504 · Received September 14, 2017

    Report

    Report Number
    6864504
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    September 11, 2017
    Report Date
    September 12, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE NURSE ENTERED ROOM, POLE-MOUNTED EXTERNAL VENTRICULOSTOMY DRAIN (EVD) WAS NOTED TO BE AT ~9CM BELOW EXTERNAL AUDITORY MEATUS (EAM). THAT IS WELL BELOW THE SET AND DESIRED LEVEL FOR THE INTEGRA NEUROSCIENCE DRAIN. THE EVD HAD 50CC DRAINED FROM THE LUMBAR DRAIN. THE PHYSICIAN WAS NOTIFIED AND EXAMINED THE PATIENT. THE EVD WAS THEN RAISED TO 10CM ABOVE THE EAM AND THE DEVICE WAS IMMEDIATELY SEEN SLIDING DOWN THE LUMBAR DRAIN POLE. MULTIPLE ATTEMPTS WERE MADE TO TIGHTEN THE SCREW ON THE POLE WITHOUT SUCCESS. THE POLE MOUNT CHANGED OUT. THE MANUFACTURER WAS CONTACTED BY THE CLINICAL NURSE SPECIALIST (CNS) ASSIGNED TO THIS NEUROSCIENCE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643910 MONITORR CSF EXTERNAL DRAINAGE SYST SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other POLE MOUNT EXTERNAL VENTRICULOSTOMY DRAIN (EVD) HO