BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 6994377 · Received November 1, 2017

    Report

    Report Number
    1610287-2017-00069
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Report Date
    March 14, 2018
    Manufacturer
    AIR LIQUIDE
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGICAL CONSOLE HAS AN AUTO GAS FILL OPTION THAT IS USED TO FILL A SYRINGE WITH A SPECIFIED OPHTHALMIC GAS. THE COLOR CODED OPHTHALMIC GAS BOTTLES MUST BE CONNECTED TO THE CONSOLE'S RED AND BLUE CONNECTORS RESPECTIVELY PER THE COLOR CODING SCHEME INDICATED IN THE OPERATOR¿S MANUAL. THE USER IS REQUIRED TO MAKE THE APPROPRIATE SELECTION OF GAS BEFORE PROCEEDING. THE SULFUR HEXAFLUORIDE OPHTHALMIC GAS DIRECTIONS FOR USE (DFU) INCLUDE CAUTIONS REGARDING OPERATIVE COMPLICATIONS AND POSTOPERATIVE COMPLICATIONS THAT MAY POTENTIALLY OCCUR. THE PRECAUTIONS NOTE CAUTION SHOULD BE USED IN EYES WITH ANGLE RECESSION, PIGMENT DISPERSION SYNDROME, SIGNIFICANT ANTERIOR SYNECHIAE, TRAUMATIZED EYES AND EYES WITH SIGNIFICANT VITREOUS HEMORRHAGE OBSCURING AN ADEQUATE VIEW OF THE PERIPHERAL RETINA. THE PATIENT MUST RECEIVE A PATIENT WARNING CARD AND BRACELET TO ADVISE ANY HEALTH CARE PROVIDER ABOUT POSSIBLE LOSS OF VISION OR BLINDNESS IF NITROUS OXIDE ANESTHESIA IS ADMINISTERED WITH A GAS BUBBLE PRESENT IN THE EYE. THE PATIENT IS CAUTIONED NOT TO TRAVEL BY PLANE, THROUGH HIGH ELEVATIONS OR OVER MOUNTAIN RANGES UNTIL THE GAS BUBBLE HAS DISSIPATED. CHANGES IN ELEVATION MAY CAUSE INTRAOCULAR PRESSURE (IOP) TO INCREASE, WHICH MAY CAUSE LOSS OF VISION OR BLINDNESS. THE PATIENT MUST MAINTAIN PROPER HEAD POSITIONING FOLLOWING EYE SURGERY. INCORRECT HEAD POSITIONING MAY CAUSE THE SURGERY TO BE UNSUCCESSFUL, OR MAY CAUSE GLAUCOMA, AND/OR MAY CAUSE CATARACTS. THERE IS NO EVIDENCE CONTAINED WITHIN THE REPORTED INFORMATION AT THIS TIME THAT INDICATES THAT THE DESIGN OR PERFORMANCE OF THE SULFUR HEXAFLUORIDE OPHTHALMIC GAS USED CONTRIBUTED TO THE EVENT REPORTED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THE PATIENT INVOLVED IN THIS REPORT WAS PREVIOUSLY REPORTED UNDER MANUFACTURING REPORT NUMBER 1610287-2017-00065. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THIS PATIENT BY THE PROCEDURE THEY HAD RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN OPHTHALMIC GAS BUBBLE WAS INSTILLED INTO A PATIENT'S EYE DURING A PARS PLANA VITRECTOMY (PPV) PROCEDURE. UPON FOLLOW UP ONE DAY POST-OP, THE GAS BUBBLE WAS MUCH SMALLER THAN EXPECTED. PATIENT IMPACT INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774818 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other