BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 7142443 · Received December 22, 2017

    Report

    Report Number
    1610287-2017-00076
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    October 30, 2017
    Report Date
    October 3, 2018
    Manufacturer
    AIR LIQUIDE
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SULFUR HEXAFLUORIDE (SF6) OPHTHALMIC GAS CYLINDER TANK WAS RETURNED TO THE CONTRACT MANUFACTURER FOR INVESTIGATION. PER THE MANUFACTURER, THE GAS IN THE CYLINDER WAS ANALYZED BY GAS CHROMATOGRAPH (GC) WHICH CONFIRMED THE GAS TO BE SULFUR HEXAFLUORIDE (SF6) WITH AN AIR CONCENTRATION OF NO MORE THAN 100 PPM. THERE WERE NO UNUSUAL GC PEAKS INDICATING THAT THE PRODUCT MET SPECIFICATIONS. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. PER THE MANUFACTURER, A REVIEW OF CONFIRMED COMPLAINTS SHOWED NO TRENDS FOR SHORT SULFUR HEXAFLUORIDE GAS BUBBLE DURATION. THE RETURNED PRODUCT MET SPECIFICATIONS THEREFORE, ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. DATA WILL CONTINUE TO BE MONITORED FOR EVIDENCE OF ADVERSE TRENDING WITH FURTHER ACTION TAKEN, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE OPHTHALMIC GAS BUBBLES INSTILLED INTO THE EYE OF TWO PATIENTS DURING SEPARATE SURGERIES WERE NOTED TO BE ONLY 75% OF THEIR ANTICIPATED SIZE AT ONE-DAY POSTOP FOLLOW UP. PROCEDURE DETAILS AND PATIENT IMPACT INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED FURTHER CONFIRMED THAT THIS REPORT FOR IS ONE IDENTIFIED PATIENT WHO RECEIVED AN OPHTHALMIC GAS BUBBLE INSTILLATION INTO THEIR EYE AT 22% GAS CONCENTRATION. THE BUBBLE WAS NOTED TO BE APPROXIMATELY 70% OF THE ANTICIPATED SIZE AT ONE-DAY POSTOP AND THEN 30% OF THE ANTICIPATED SIZE AT ONE-WEEK POSTOP. THE TREATED MACULAR HOLE, WHICH WAS LARGE, HAD NOT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923955 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE NA 630813

    Patients

    Seq Age Sex Outcome Treatment
    1 Other