BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN TM PERFLUOROPROPANE (C3F8) GAS

    MDR report key: 1632538 · Received March 4, 2010

    Report

    Report Number
    2518435-2010-00004
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Report Date
    February 19, 2010
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 FACILITY REPORTED THAT PERFLUOROPROPANE DID NOT RETAIN REQUIRED DENSITY ON THE DAY FOLLOWING SURGERY ON TWO PATIENTS. THE GAS ONLY RETAINED DENSITY OF 60-70% ON THE DAY FOLLOWING SURGERY THROUGH NORMALLY IT IS 90%. THE EVENT DATE WAS NOT PROVIDED. NO PATIENT IDENTIFIERS WERE PROVIDED. THE PATIENT OUTCOMES WERE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN TM PERFLUOROPROPANE (C3F8) GAS LPO/INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION C3F8, 125 G 800314

    Patients

    Seq Age Sex Outcome Treatment
    1