BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2072404 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00340
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPRESENTATIVE EXAMINED THE SYSTEM, REPLACED THE INFUSION MANIFOLD, THEN TESTED THE SYSTEM AND FOUND IT MET SPECIFICATIONS. THE COMPANY REPRESENTATIVE FOUND NO PROBLEMS RELATED TO THE KEY OF THE LASER, OR TO LASER SHUT DOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING A PROCEDURE, THE CASSETTE WAS LEAKING AND THE INFUSION STOPPED JUST BEFORE APPLYING LASER. IN ADDITION, THE NURSE REPORTED THAT THE LASER KEY DISPLAYED A BAD CONNECTION AND THE KEY HAD TO BE POSITIONED IN A PARTICULAR WAY TO KEEP THE LASER TURNED ON. THE SYSTEM WAS EXCHANGED TO COMPLETE THE CASE WITHOUT HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1