BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN SULFUR HEXAFLUORIDE (SF6) GAS

    MDR report key: 8577553 · Received May 3, 2019

    Report

    Report Number
    1610287-2019-00011
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Report Date
    July 23, 2019
    Manufacturer
    AIR LIQUIDE
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE VISION SYSTEM CONSOLE HAS AN AUTO GAS FILL OPTION THAT IS USED TO FILL A SYRINGE WITH A SPECIFIED OPHTHALMIC GAS. THE OPHTHALMIC GAS BOTTLES ARE COLOR CODED AND MUST BE CONNECTED PER THE COLOR CODING SCHEME INDICATED IN THE CONSOLE OPERATOR¿S MANUAL. THE COLOR CODED GAS TANKS MUST BE USED WITH THE CORRESPONDING RED AND BLUE CONNECTORS RESPECTIVELY. THE USER IS REQUIRED TO MAKE THE APPROPRIATE SELECTION OF GAS BEFORE PROCEEDING. THE OPERATOR¿S MANUAL STATES: ¿THE GAS MIX RATIO GUIDE IS A TOOL TO ASSIST THE USER IN CALCULATING THE SYRINGE VOLUME ADJUSTMENTS REQUIRED IN ORDER TO ACHIEVE THE DESIRED MIXTURE. NOTE: ¿ADJUSTING THE GAS MIX RATIO GUIDE DOES NOT AUTOMATICALLY FILL THE SYRINGE TO THE DESIRED MIXTURE. THE USER MUST MANUALLY MOVE THE PLUNGER TO MAKE THE GAS VOLUME ADJUSTMENT IN THE SYRINGE AFTER DETACHING THE SYRINGE ASSEMBLY FROM THE CONSOLE.¿ TO ACHIEVE A SPECIFIC GAS/AIR MIX RATIO (AFTER THE SYSTEM HAS PURGED THEN FILLED THE SYRINGE WITH 20CC OF GAS), USE THE GAS MIX RATIO GUIDE AS FOLLOWS: MOVE THE SLIDER ON THE GUIDE TO THE DESIRED PERCENT OF GAS MIXTURE. THE GUIDE DISPLAYS THE SYRINGE READING THAT THE PLUNGER MUST BE MOVED TO IN ORDER TO ACHIEVE THE DISPLAYED PERCENTAGE OF GAS IN THE SYRINGE (18% -> 10.8 CC IN THE AUTO GAS FILL POPUP). FOR AN 18% GAS MIXTURE, PUSH THE PLUNGER FROM 20CC TO 10.8CC. THEN PULL THE PLUNGER OUT TO 60CC. THE RESULTING MIXTURE WILL BE 18% OF THE SELECTED GAS. 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 (N20) 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 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 CONTRIBUTED TO THE EVENT REPORTED. THE SULFUR HEXAFLUORIDE GAS WAS NOT RETURNED FOR EVALUATION. THE GAS LOT NUMBER WAS NOT PROVIDED AND COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED THEREFORE, MANUFACTURING INFORMATION COULD NOT BE OBTAINED. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT COULD NOT BE CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. DATA WILL CONTINUE TO BE MONITORED FOR EVIDENCE OF ADVERSE TRENDING WITH FURTHER ACTION TAKEN, AS APPROPRIATE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A BUBBLE OF OPHTHALMIC GAS WAS INSTILLED INTO A PATIENT'S EYE DURING A VITRECTOMY WITH SCLERAL BUCKLE SURGERY. THE GAS BUBBLE DID NOT LAST AS LONG AS EXPECTED. PATIENT IMPACT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373669 ISPAN SULFUR HEXAFLUORIDE (SF6) GAS INTRAOCULAR GAS LPO AIR LIQUIDE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1