BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 5418804 · Received February 9, 2016

    Report

    Report Number
    2028159-2016-00544
    Event Type
    Death
    Date Received
    February 9, 2016
    Report Date
    February 10, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A SYSTEM MESSAGE (SM) DISPLAYED. THE PATIENT ARRESTED AND DIED ON THE OPERATING ROOM TABLE. THE PATIENT HAD BLOOD IN THE MOUTH. THE CAUSE OF DEATH WAS DETERMINED TO BE PULMONARY EDEMA. ADDITIONAL INFORMATION WAS REQUESTED WITH NO INFORMATION RECEIVED TO DATE. PULMONARY EDEMA IS A CONDITION CAUSED BY EXCESS FLUID IN THE LUNGS. THIS FLUID COLLECTS IN THE NUMEROUS AIR SACS IN THE LUNGS, MAKING IT DIFFICULT TO BREATHE. SYMPTOMS OF PULMONARY EDEMA MAY INCLUDE: COUGHING UP BLOOD OR BLOODY FROTH; DIFFICULTY BREATHING WHEN LYING DOWN (ORTHOPNEA); FEELING OF "AIR HUNGER" OR "DROWNING" (THIS FEELING IS CALLED "PAROXYSMAL NOCTURNAL DYSPNEA" IF IT CAUSES YOU TO WAKE UP AND TRY TO CATCH YOUR BREATH.); GRUNTING, GURGLING, OR WHEEZING SOUNDS WITH BREATHING; OR PROBLEMS SPEAKING IN FULL SENTENCES BECAUSE OF SHORTNESS OF BREATH. IN MOST CASES, HEART PROBLEMS CAUSE PULMONARY EDEMA. BUT FLUID CAN ACCUMULATE FOR OTHER REASONS, INCLUDING PNEUMONIA, EXPOSURE TO CERTAIN TOXINS AND MEDICATIONS, TRAUMA TO THE CHEST WALL, AND EXERCISING OR LIVING AT HIGH ELEVATIONS. PULMONARY EDEMA THAT DEVELOPS SUDDENLY (ACUTE PULMONARY EDEMA) IS A MEDICAL EMERGENCY REQUIRING IMMEDIATE CARE. ALTHOUGH PULMONARY EDEMA CAN SOMETIMES PROVE FATAL, THE OUTLOOK IMPROVES WHEN YOU RECEIVE PROMPT TREATMENT FOR PULMONARY EDEMA ALONG WITH TREATMENT FOR THE UNDERLYING PROBLEM. TREATMENT FOR PULMONARY EDEMA VARIES DEPENDING ON THE CAUSE BUT GENERALLY INCLUDES SUPPLEMENTAL OXYGEN AND MEDICATIONS. THERE IS NO EVIDENCE CONTAINED WITHIN THE REPORTED INFORMATION AT THIS TIME THAT INDICATES THAT THE DESIGN OR PERFORMANCE OF THE SYSTEM CAUSED OR CONTRIBUTED TO THE EVENT.¿ PRODUCT EVALUATION THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS NOT REPLICATED. PNEUMATIC MODULE AND THE OIL/AIR FILTER DRYER WERE REPLACED AS A PREVENTATIVE MEASURE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE SYSTEM WAS MANUFACTURED ON JULY 23, 2013. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM DISPLAYED A SYSTEM MESSAGE DURING SURGERY. THE SYSTEM WAS EXCHANGED TO TRY AND RESUME THE SURGERY WITH THE SAME CONSUMABLE. THE PATIENT DIED ON THE TABLE. THE CAUSE OF DEATH WAS DETERMINED TO BE PULMONARY EDEMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN RECEIVED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78672 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death