BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 17469060 · Received August 7, 2023

    Report

    Report Number
    2518435-2023-00024
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Report Date
    October 25, 2023
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657970025
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION WILL SERVE FOR THE SUSPECT REGULATOR REPORTED. HOWEVER, THIS REGULATOR WAS NOT RETURNED FOR TESTING ON THIS INVESTIGATION. A CHECK OF THE BATCH PRODUCTION RECORD FOR THE REGULATOR COULD NOT BE PERFORMED BECAUSE A VALID LOT NUMBER WAS NOT REPORTED. THE MANUFACTURING DATE COULD NOT BE DETERMINED. A CHECK OF THE COMPLAINT RECORDS FOR THE REGULATOR LOT COULD NOT BE PERFORMED BECAUSE A VALID LOT NUMBER WAS NOT PROVIDED. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 29 COMPLAINTS SINCE THE BEGINNING OF 2016. NO SAMPLE WAS RETURNED. TESTING COULD NOT BE PERFORMED ON REGULATOR. NO SAMPLE WAS RETURNED FOR EVALUATION. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. 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 HEALTHCARE PROFESSIONAL REPORTED THAT THE ISSUE OF THE GAS NOT DECANTING PROPERLY HAS BEEN FOR AN EXTENDED PERIOD OF TIME WITH NUMEROUS PATIENTS. ALL SURGERIES WERE ABLE TO BE COMPLETED WITHOUT INCIDENT, EITHER BY WAITING FOR A VERY LONG TIME FOR THE SF6 TO FLOW, OR BY SURGEON CHANGING TO DIFFERENT GAS. ALL PROCEDURES WERE RETINAL VITRECTOMIES. NO SYSTEM USED TO GIVE MESSAGE OR WARNING. NO PATIENT HARM OR SURGICAL COMPLICATION, SIMPLY DELAYED PROCEDURE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323226 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 232611 00380657970025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown