BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 17624222 · Received August 25, 2023

    Report

    Report Number
    2518435-2023-00028
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    July 10, 2023
    Report Date
    November 2, 2023
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657971022
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CHECK OF THE BATCH PRODUCTION RECORD SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED NO OTHER COMPLAINTS AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR C3F8 (PFP) UTILIZATION RESULTING IN LOW GAS CONTENT IN THE EYE AND/OR ANTERIOR CHAMBER FLICKER SHOWED NO OTHER COMPLAINTS SINCE THE BEGINNING OF 2016. THERE WAS NO SAMPLE RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE THIS LOT SHOWED THAT THE PRODUCT WAS PFP AND MET AIL RELEASE CRITERIA. NOTHING WAS FOUND THAT WOULD ACCOUNT FOR THE REPORTED EVENT. 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 CLINICAL STUDY REPORTED THAT 60 YEARS OLD FEMALE PATIENT UNDERWENT POSTERIOR VITRECTOMY SURGERY, SURGEON FOUND THAT THE OPHTHALMIC GAS CONTENT WAS LESS THAN HALF DURING THE SURGERY. AGAIN, SURGERY WAS CONDUCTED FOR OPHTHALMIC GAS INSTALLATION IN THE EYE. AFTER THE SURGERY, SURGEON OBSERVED THAT THERE WAS ANTERIOR CHAMBER FLICKERS IN THE EYE, BLOOD CELLS ATTACHED ON CORNEA, CELLS, HIGH CRYSTAL DENSITY NOTED IN PATIENT EYE. SYMPTOMS WERE TREATED WITH MEDICATIONS. SYMPTOMS ARE IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282816 ISPAN PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC NA 216804 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization| O| R