BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN TM PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 1847002 · Received September 24, 2010

    Report

    Report Number
    2518435-2010-00013
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT BY GAS CHROMATOGRAPH (GC) SHOWED THAT THE PRODUCT MET PURITY SPECIFICATION AND THAT NO UNUSUAL PEAKS WERE SEEN COMPARED TO THE ORIGINAL GC. A CHECK OF THE BATCH PRODUCTION RECORDS SHOWED THAT THE ORIGINAL GC ANALYSIS MET PURITY SPECIFICATION. THERE HAVE BEEN NO OTHER REPORTS INVOLVING THIS LOT NUMBER. NO CONCLUSION CAN BE DRAWN. THIS REPORT MAILED IN TO THE FDA ON: (B)(4) 2010.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THE BUBBLE WAS NOT HOLDING. THE DOCTOR FOUND ON THE FIRST DAY POST-OP THAT A PATIENT'S EYE PRESSURE WAS 80% INSTEAD OF 100% AND THAT THERE COULD BE A PROBLEM WITH THE GAS TANK. NO PATIENT IDENTIFIERS WERE PROVIDED. THE PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN TM PERFLUOROPROPANE (C3F8) GAS INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION C3F8, 125 G 902208

    Patients

    Seq Age Sex Outcome Treatment
    1