BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2982981 · Received February 26, 2013

    Report

    Report Number
    2028159-2013-00231
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    January 28, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN REC'D FOR EVAL. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AIR FLOWED FREELY WHEN AIR AND INFUSION WERE TURNED OFF DURING A VITRECTOMY PROCEDURE. BUBBLES CAME THROUGH THE INFUSION LINE THAT WAS CONNECTED TO THE CASSETTE, INFUSION LINE, AND "3 WAY TAP" WERE EXCHANGED BUT DID NOT CORRECT THE PROBLEM. THE SYSTEM WAS THEN EXCHANGED, BUT THE SAME ISSUED OCCURRED. THE CASSETTE WAS EXCHANGED AGAIN WHICH CORRECTED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81901 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 GAUGE COMBINED PACK 5.0 CPM