BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFLUORON

    MDR report key: 15950919 · Received December 9, 2022

    Report

    Report Number
    1610287-2022-00080
    Event Type
    Death
    Date Received
    December 9, 2022
    Date of Event
    December 1, 2022
    Report Date
    March 30, 2023
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LWL
    PMA / PMN Number
    P950018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. PERFLUOROCARBON SYNDROME-A POSSIBLE, OVERLOOKED SOURCE OF FATAL GAS EMBOLISM FOLLOWING UVEAL-MELANOMA ENDORESECTION. R. H, M.R., M.F., G.K.L., L.W., B.E.D., .D. C., EYE (LONDON, ENGLAND) 2022: 36(12) P.2348-2349. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    NO SAMPLE OR LOT CODE WAS RETURNED; THEREFORE, LOT SPECIFIC EVALUATION CANNOT BE COMPLETED, AT THIS TIME. ALL COMPOUNDING, PREPROCESSING, FILLING AND PACKAGING MBRS ARE SUBJECTED TO 2 INDEPENDENT REVIEWS. IN ADDITION, THE FOLLOWING ARE REVIEWED: ALL CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS ENVIRONMENTAL, UTILITY, BIOBURDEN RECORDS SANITIZATION RECORDS. STERILIZATION CYCLES (FOR MOST COUNTIES, PERFLUORON IS PACKAGED INTO A KIT THAT CONTAINS THE SYRINGE, NEEDLE, FILTER, A PRODUCT INSERT, AND THE PERFLUORON UNIT). THE PRODUCT IS MANUFACTURED ACCORDING TO REQUIREMENTS OF THE PERFLUORON DEVICE MASTER RECORD. THE PRODUCT IS STERILIZED VIA FILTRATION AND FILLED INTO DRY HEAT STERILIZED VIALS THAT ARE SEALED WITH STERILIZED STOPPERS. FINISHED PRODUCT TESTING INCLUDES INFRARED ADSORPTION, UF ABSORPTION, MNR, PURITY OF PFNO (GAS CHROMATOGRAPHY), PARTICULATE ANALYSIS, BIOBURDEN AND STERILITY. ALL TESTING FOR THE PRODUCT LOTS ARE REQUIRED TO MEET SPECIFICATIONS PRIOR TO RELEASE. THE PRODUCT INSERT PROVIDES INDICATIONS, INSTRUCTIONS, AND STORAGE CONDITION. CUSTOMER PRODUCT STORAGE AND USE COULD NOT BE CONFIRMED. THE PRODUCT LABELING FOR PERFLUORON PROVIDES INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND DIRECTIONS FOR USE TO ENSURE PROPER USE OF THE PRODUCT. INSTRUCTIONS ALSO STATE, ¿ALL COMPONENTS FOR SINGLE USE ONLY¿. ROOT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE DETERMINED. POTENTIAL ROOT CAUSES: SOLUTION QUALITY ISSUE ¿CHEMISTRY AND MICROBIOLOGY DATA MUST MEET REGULATORY REQUIREMENTS PRIOR TO RELEASE. CONSUMER MISHANDLING - NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF CONSUMER MISHANDLING AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. EVENT RELATED TO CONSUMER PHYSIOLOGY ¿ NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF UNIQUE CONSUMER PHYSIOLOGY AS THIS FACTOR IS OUTSIDE THE CONTROL OF THE MANUFACTURING FACILITY. EVENT RELATED TO SURGICAL TECHNIQUE ¿ NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF SURGICAL TECHNIQUE. LOT SPECIFIC EVALUATION IS NOT POSSIBLE DUE TO THE LACK OF LOT CODE REPORTED. NO FURTHER ACTION IS WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED VIA LITERATURE ARTICLE STATED THAT THE PATIENT UNDERWENT CHOROIDAL MELANOMA ENDO RESECTION UNDER GENERAL ANESTHESIA AND THE RETINA WAS STABILIZED WITH PERFLUORON WITH A POSSIBLE EGRESS OF 8CC INTO THE PULMONARY CIRCULATION. THE PATIENT WAS MONITORED, RECOVERED UNEVENTFULLY AND WAS DISCHARGED THE SAME DAY WITHOUT APPARENT DISCOMFORT OR DIFFICULTY. THE PATIENT WAS SUDDENLY FEELING UNWELL, ACUTELY SHORT OF BREATH 4.5-5 HOURS AFTER THE OPERATION AND TRANSFERRED TO INTENSIVE CARE, WHERE HE SUSTAINED A HYPOXIC CARDIAC ARREST. COMPUTERIZED TOMOGRAPHY (CT) CORONARY ANGIOGRAM SHOWED AIR EMBOLISM AND THE PATIENT DIED DUE TO AIR EMBOLISM 18 HOURS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2702048 PERFLUORON FLUID, INTRAOCULAR LWL ALCON RESEARCH, LLC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| O| D