BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3941850 · Received June 3, 2014

    Report

    Report Number
    2028159-2014-01023
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE INFUSION CANNULA LEAKED DURING THE SURGERY. A SYSTEM MESSAGE WAS DISPLAYED. A NEW PAK WAS OPENED AND THE SURGERY WAS DELAYED FIVE MINUTES IN SURGEON'S OPINION, THIS DELAY WAS NOT CONSIDERED AS CLINICALLY SIGNIFICANT. THE PATIENT DID NOT EXPERIENCE ANY HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324014 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUSTOM PAK| 20 GA TOTALPLUS VITRECTOMY PAK