BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 16643265 · Received March 30, 2023

    Report

    Report Number
    2518435-2023-00007
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    January 4, 2023
    Report Date
    June 27, 2023
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657970049
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CHECK OF THE BATCH PRODUCTION RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE EXPIRATION DATE COULD NOT BE DETERMINED. A CHECK OF THE COMPLAINT RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. A CHECK OF CONFIRMED COMPLAINTS FOR SF6 EYE GAS NOT LASTING AS LONG IN THE PATIENT'S EYE AS EXPECTED SHOWED NO COMPLAINTS. THE SAMPLE WAS NOT RETURNED. TESTING COULD NOT BE PERFORMED. NO SAMPLE WAS RETURNED FOR EVALUATION. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE REPORTED EVENT WAS NOT CONFIRMED. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT OPHTHALMIC OPERATING CONSOLE WAS NOT DISPENSING SULPHUR HEXAFLUORIDE GAS AND GAS BUBBLE IN PATIENT EYE WAS REDUCED TO UNUSUAL SIZE IT WAS NOTICED ON POST OPERATIVE DAY EIGHT. THERE WERE NO DETAILS OF THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172667 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA ASKU 00380657970049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONSTELLATION VISION SYSTEM.| CONSTELLATION VISION SYSTEM.