BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION

    MDR report key: 1941924 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02431
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT LOG FROM THE SYSTEM IS EXPECTED TO BE RETURNED FOR EVALUATION, BUT HAS NOT YET ARRIVED. 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. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE, WHO WAS ATTENDING SURGERY ON THE DATE OF THE EVENT, REPORTED THAT DURING A CASE, THERE WAS AN INFUSION FAILURE. THE CASSETTE WAS EXCHANGED AND THE PROBLEM PERSISTED. THE SYSTEM WAS EXCHANGED AND THE CASE WAS COMPLETED WITH A DELAY OF APPROXIMATELY ONE HOUR. THE PATIENT HAD BEEN ANESTHETIZED WITH PERIBULBAR ANESTHETIC. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other