BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2844587 · Received November 12, 2012

    Report

    Report Number
    2028159-2012-01701
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DHR (DEVICE HISTORY RECORD) AND LOT HISTORY COULD NOT BE REVIEWED. A SAMPLE WAS EXPECTED FOR THIS INVESTIGATION BUT HAS NOT YET BEEN RECEIVED. IF A SAMPLE IS RETURNED AT A LATER DATE, THE INVESTIGATION WILL BE REOPENED AND THE SAMPLE EVALUATED. THE ROOT CAUSE IS UNKNOWN. A SAMPLE WAS NOT RETURNED FOR THIS COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE EQUIPMENT DID NOT RECOGNIZE THE INFUSION CHAMBER AND THE PROBE. WHEN THE EQUIPMENT DID RECOGNIZE IT, THERE WERE BUBBLES IN THE PROBE. THE CASSETTE WAS REPLACED BUT A SYSTEM MESSAGE DISPLAYED AND IT DID NOT CALIBRATE. THE CASSETTE WAS REPLACED AGAIN AND THE EQUIPMENT SUCCESSFULLY PERFORMED THE CALIBRATION. SURGERY HAD NOT YET BEGUN, BUT THE PATIENT WAS IN THE SURGICAL ROOM AND HAD RECEIVED PERIBULBAR ANESTHESIA. THE EVENTS RESULTED IN A DELAY OF 30 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1