BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GFI TUBING SET

    MDR report key: 473827 · Received July 23, 2003

    Report

    Report Number
    1644019-2003-00020
    Event Type
    Injury
    Date Received
    July 23, 2003
    Date of Event
    June 23, 2003
    Report Date
    June 23, 2003
    Manufacturer
    ALCON - HOUSTON
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED HIGH IOP RESULTED IN RETINAL INJURY DURING SURGERY. UNABLE TO REDUCE HIGH IOP WITH FIRST SYSTEM. RE-SPIKED BOTTLE AND RELEASED A STRONG BACK PRESSURE. CHANGED TO ANOTHER SYSTEM; STILL HAD HIGH IOP. DEVICE WAS DISCONNECTED, NOTED HIGH BACK PRESSURE AGAIN. SAME DEVICE WAS RE-SPIKED FOR A THIRD TIME AND CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GFI TUBING SET FLUID/GAS EXCHANGE SET HQE ALCON - HOUSTON GFI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other