BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 11071902 · Received December 24, 2020

    Report

    Report Number
    1610287-2020-00040
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    December 17, 2020
    Report Date
    March 18, 2021
    Manufacturer
    AIR LIQUIDE
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN OPHTHALMIC GAS SAMPLE WAS RECEIVED AND PUT THROUGH FINAL INSPECTION AND TESTING. THERE WAS NO PROBLEM FOUND WITH THE SAMPLE RELATED TO THE REPORTED EVENT. THE PRODUCT MET SPECIFICATIONS UPON SAMPLE TESTING. A REVIEW OF THE BATCH PRODUCTION RECORD FOR THE REPORTED LOT WAS PERFORMED AND CONFIRMED THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF COMPLAINTS FOR THE LAST 12 MONTHS DID NOT INDICATE ANY ADDITIONAL RELATED REPORTS FOR THIS REPORTED LOT NUMBER OF OPHTHALMIC GAS. NO PROBLEM WAS FOUND WITH THE OPHTHALMIC GAS SAMPLE THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPORT SUBMITTED FOR THIS EVENT CONTAINED AN ERROR IN H1: ¿SUMMARY REPORT¿ WAS INADVERTENTLY SELECTED. AFTER A RECENT SYSTEMS UPDATE, A SYSTEM ERROR CAUSED THE INADVERTENT ADDITIONAL SELECTION OF ¿SUMMARY REPORT¿ IN H.1. ON A SELECT NUMBER OF REPORTS. THE ERROR, WHICH WAS LIMITED ONLY TO THE H.1. FIELD, WAS PROMPTLY IDENTIFIED AND QUICKLY RECTIFIED. CORRECTION SMDRS ARE BEING FILED FOR THE IMPACTED REPORTS. THIS SMDR IS CORRECTING THAT ERROR FOR THIS EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FURTHER CLARIFIED THAT 20% OPHTHALMIC GAS CONCENTRATION MIXED WITH ROOM AIR WAS INSTILLED INTO THE PATIENT'S EYE DURING THEIR INITIAL PARS PLANA VITRECTOMY WITH ENDOLASER SURGERY TO TREAT A RETINAL DETACHMENT. THE INSTILLED BUBBLE WAS ONLY 55% OF THE ANTICIPATED SIZE UPON SEVEN DAYS POST-OP. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS STABLE.

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION 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. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN OPHTHALMIC GAS WAS RESORBING MORE QUICKLY INSIDE OF THE PATIENT'S EYE THAN IT USED TO. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535080 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE NA 925609

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR