BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2479809 · Received March 2, 2012

    Report

    Report Number
    2028159-2012-00123
    Event Type
    Death
    Date Received
    March 2, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND NO PROBLEMS WERE FOUND. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THE COMPANY CLINICAL ANALYST REVIEWED THE FILE. THE EVENT REPORTED IS A RARE AND PRACTICALLY UNK COMPLICATION IN VITREORETINAL SURGERY. AIR EMBOLISM IS PRIMARILY AN IATROGENIC COMPLICATION THAT OCCURS WHENEVER ATMOSPHERIC GAS IS INTRODUCED INTO THE SYSTEMIC VASCULAR SYSTEM AND IS PROBABLY THE MOST COMMON EMBOLIC EVENT TO OCCUR IN SURGICAL PROCEDURES. IF AIR ENTERS THE CIRCULATORY SYSTEM IN SMALL AMOUNTS OR AT VERY SLOW RATES, IT IS POSSIBLE FOR THE AIR TO BE PHYSIOLOGICALLY ABSORBED INTO THE BLOOD OR REMOVED VIA THE ALVEOLI WITHOUT CAUSING SIGNIFICANT PROBLEMS. ITS MANIFESTATION RANGES FROM SUBCLINICAL TO FATAL. IT HAS BEEN MOSTLY ASSOCIATED WITH NEUROSURGICAL PROCEDURES, CENTRAL VENOUS CATHETERIZATION, CHEST AND HEAD TRAUMA, AND SEVERAL OTHER INVASIVE VASCULAR PROCEDURES. THE OCCURRENCE OF AIR EMBOLISM WHEN PERFORMING AIR-FLUID EXCHANGE IN CURRENT AVAILABLE LITERATURE IS CURRENTLY ONLY THEORETICAL, IF NOT SPECULATIVE. THERE ARE TO DATE NO SCIENTIFIC AND CLEAR CLINICAL EVIDENCE THAT THEY ARE IN ANY WAY RELATED. CURRENT PUBLISHED REPORTS HOLD TENUOUS CLAIMS AT BEST AS THEY ARE NOT SUPPORTED BY TECHNICAL AND ANATOMICAL REALITIES AND/OR FACTS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE SYSTEM DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THERE WERE NO NON-CONFORMITIES RELATED TO FAX OR FLUIDICS. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, A DIRECTOR OF NURSING AT A FACILITY REPORTED A DEATH HAD OCCURRED WHILE THE SURGEON WAS PERFORMING A FLUID TO AIR EXCHANGE (FAX) WHILE USING THEIR NORMAL SETUP FOR A PLANNED RETINAL DETACHMENT PROCEDURE WITH SCLERAL BUCKLE. THE SURGEON SUGGESTED THAT THE PT MAY HAVE HAD AIR EMBOLISMS BUT THE CAUSE OF DEATH HAS NOT YET BEEN DETERMINED. PRIOR TO SURGERY, THE PT HAD RECEIVED GENERAL ANESTHESIA WITH A LARYNGEAL MASK AIRWAY (LMA), BUT WAS CONVERTED TO AN ENDOTRACHEAL TUBE AFTER THE PT HAD CODED. AN AUTOPSY WAS PERFORMED ON (B)(6) 2012 AND THE RESULTS ARE NOT EXPECTED TO BE RECEIVED FOR APPROX 2 WEEKS. PRELIMINARY AUTOPSY FINDINGS INDICATED DISTAL AORTIC DISEASE. ALTHOUGH THE SITE DOES NOT BELIEVE THE INCIDENT WAS SYSTEM RELATED AS NO ERROR MESSAGES WERE RECEIVED, A SERVICE VISIT WAS REQUESTED TO CAPTURE THE SYSTEM LOG AND TO HAVE THE SYSTEM CHECKED OUT. A COMPANY SERVICE REP VISITED THE SITE ON (B)(6) 2012. THE SYSTEM WAS CHECKED AND NO PROBLEMS WERE FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BSS