BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION LXT

    MDR report key: 5839398 · Received August 2, 2016

    Report

    Report Number
    5839398
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 28, 2016
    Manufacturer
    ALCON
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WITHIN ONE MINUTE OF A VITRECTOMY FOR A RETINAL DETACHMENT THE ALCON CONSTELLATION VITRECTOMY LXT UNIT SUDDENLY SHOWED AN ERROR CODE AND QUIT FUNCTIONING. THE EQUIPMENT SPECIALIST WAS CALLED TO BRING A SECOND CONSTELLATION UNIT TO THE OPERATING ROOM STAT. ALCON TECH SUPPORT WAS ALSO CALLED BUT THERE WAS NOTHING THEY COULD DO TO HELP US. WE HAD TO COMPLETELY SHUT DOWN THE UNIT. WE TRIED TO RESTART IT BUT IT WOULD NOT RESPOND. A SECOND CONSTELLATION MACHINE HAD ARRIVED IN THE OPERATING ROOM. WE BOOTED IT UP, TRANSFERRED TUBING, AND WERE ABLE TO CONTINUE THE CASE. THERE WAS APPROXIMATELY A 20 MINUTE DELAY. DR WAS CONCERNED THAT THE RETINA MAY HAVE RE-DETACHED BUT IT APPEARED NOT TO HAVE. ALCON FIELD SERVICE WAS CALLED IN FOR REPAIR. IT WAS DISCOVERED THE PNEUMATIC FUNCTIONS WERE DISABLED. SERVICE TECHNICIAN REPLACED THE FILTER, OIL/AIR DRYER INTAKE MANIFOLD ASSEMBLY AND THE PNEUMATICS DISTRIBUTION CABLE. UNIT WAS RETURNED TO SERVICE. MANUFACTURER RESPONSE FOR VITRECTOMY MACHINE, CONSTELLATION LXT (PER SITE REPORTER): A FIELD SERVICE TECHNICIAN CAME TO OUR FACILITY AND REPAIRED THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492884 CONSTELLATION LXT UNIT, PHACOFRAGMENTATION HQC ALCON LXT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR NO