BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 14445276 · Received May 19, 2022

    Report

    Report Number
    1610287-2022-00028
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 8, 2022
    Report Date
    September 27, 2022
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657971053
    PMA / PMN Number
    P900066
    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

    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).

    Additional Manufacturer Narrative · 0

    THE C3F8 GAS TANK WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE BATCH PRODUCTION RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE EXPIRATION DATE COULD NOT BE DETERMINED. A REVIEW OF THE COMPLAINT RECORDS COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF CONFIRMED COMPLAINTS FOR LEAKING CYLINDERS OF THIS TYPE OR FOR C3F8 NOT LASTING AS LONG AS EXPECTED. BOTH WERE FOR CYLINDERS THAT LEAKED AT THE VALVE TO CYLINDER CONNECTION. 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).

    Description of Event or Problem · 0

    THIS REPORT REPRESENTS GAS INVOLVED IN THIS EVENT. A PHYSICIAN REPORTED THAT AFTER A VITRECTOMY PROCEDURE FOR RECURRENT RETINAL DETACHMENT, ON POST OPERATIVE DAY 10 THE SURGEON FOUND ONLY 30% OF GAS WAS FILLED IN PATIENT¿S EYE, THEY NOTICED THE SYSTEM WAS IMPROPERLY DISPENSED GAS AND WAS LEAKING SOMEWHERE THAT CAUSED ROOM AIR TO BE DRAWN UP. IT WAS INFORMED THAT AN OPHTHALMIC GAS AND AN OPHTHALMIC OPERATING CONSOLE WERE USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911532 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA ASKU 00380657971053

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONSTELLATION VISION SYSTEM