BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS, TOTAL PLUS PAK

    MDR report key: 1082890 · Received July 8, 2008

    Report

    Report Number
    1082890
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 9, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCURUS MACHINE SCREEN SAID "CASSETTE DRAINING, PLEASE WAIT". CASSETTE WAS NOT DRAINING. THEN MACHINE SCREEN SAID "CASSETTE FULL, CHANGE CASSETTE." NO LIQUID WAS IN THE BAG OF THE CASSETTE; ONLY LIQUID IN THE CHAMBER OF THE CASSETTE. THE RN PULLED THE SIDES OF THE BAG APART WITH NO CHANGE IN THE PROBLEM. THE RN EJECTED THE CASSETTE AND REPLACED IT WITH A NEW CASSETTE WITH NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS, TOTAL PLUS PAK PAK, PROBE, VITRECTOMY HQC ALCON LABORATORIES, INC. * 8015200X-2008-03

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR