BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRAFLOW

    MDR report key: 13236698 · Received January 11, 2022

    Report

    Report Number
    MW5106588
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 7, 2022
    Manufacturer
    IRRAS USA, INC.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    I CALLED ON 12/29 TO TALK TO THE BEDSIDE NURSE ABOUT THE IRRAFLOW THAT WAS IN USE AND THAT HAD BEEN PLACED THE NIGHT BEFORE TO SEE HOW THINGS WERE GOING. CHARGE INFORMED ME THAT THE DRAIN WAS LEAKING AND DRAINING CSF ONTO A CHUCK IN THE BED FROM THE SPOT ON THE CATHETER THAT THE CLAMP WAS USED AND THAT THE CONNECTOR TO THE TUBING SET LOOKED CRACKED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331521 IRRAFLOW DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM IRRAS USA, INC. IRRAFLOW 1009134

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male