BEUDAMED
    FDA Adverse Event Other Summary report: N

    IRRAFLOW

    MDR report key: 20471454 · Received October 16, 2024

    Report

    Report Number
    MW5161125
    Event Type
    Other
    Date Received
    October 16, 2024
    Report Date
    October 15, 2024
    Manufacturer
    IRRAS USA, INC.
    Product Code
    GWM
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM DEEPLY CONCERNED ABOUT THE INAPPROPRIATE USE OF THE IRRAFLOW INTRAVENTRICULAR IRRIGATION SYSTEM WITHIN THE DEPARTMENT OF (B)(6). THE IRRAFLOW SYSTEM IS DESIGNED TO PROVIDE DYNAMIC INTRACRANIAL PRESSURE CONTROL VIA CONTINUOUS IRRIGATION AND DRAINAGE OF CEREBROSPINAL FLUID (CSF) FOR TREATING CONDITIONS SUCH AS INTRAVENTRICULAR HEMORRHAGE AND INFECTION. HOWEVER, RECENT EVIDENCE SUGGESTS ITS APPLICATION AT UNM HAS RESULTED IN UNNECESSARY HARM TO MULTIPLE PATIENTS DUE TO CARELESS USE, INADEQUATE TRAINING OF MEDICAL PERSONNEL, AND POSSIBLE DESIGN FLAWS. PLEASE READ BELOW. REPORTS OF SEVERE INFECTIONS, MECHANICAL FAILURES, AND IMPROPER PRESSURE SETTINGS CAUSING INTRACRANIAL PRESSURE IMBALANCES HIGHLIGHT THE URGENT NEED FOR PROPER TRAINING AND GUIDELINES TO ENSURE SAFE AND EFFECTIVE USE OF THIS DEVICE. REFERENCE REPORT MW5161124.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243472 IRRAFLOW DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM IRRAS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown