BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISPAN PERFLUOROPROPANE GS

    MDR report key: 1321118 · Received February 20, 2009

    Report

    Report Number
    2518435-2009-00004
    Event Type
    Other
    Date Received
    February 20, 2009
    Date of Event
    January 22, 2009
    Report Date
    January 27, 2009
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    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 ANALYSIS. A CHECK OF THE BATCH PRODUCTION RECORDS SHOWED NO PROCESS OR ANALYSIS ISSUES. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    NURSE REPORTED THAT ONE DAY AFTER INSTILLING GAS, NO BUBBLE WAS FOUND IN THE PT'S EYE. FIRST PROCEDURE PERFORMED (B)(6) 2009. THE PFP WAS USED AT 100%. SECOND PROCEDURE PERFORMED (B)(6) 2009. BUBBLE OBSERVED IN PT'S EYE AS INTENDED (B)(6) 2009. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN PERFLUOROPROPANE GS PRODUCT CODE LPO/INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION C3F8, 450 G 803815

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other