BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    MDR report key: 1021555 · Received March 24, 2008

    Report

    Report Number
    6000002-2008-06337
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 30, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. EXAMINATION REVEALED THAT DRY BLOOD WAS EVIDENT INSIDE THE THERMISTOR CONNECTOR AND THE THERMISTOR LUMEN. A SLIT, ABOUT .12 INCHES LONG WAS OBSERVED AT THE PROXIMAL END OF THE THERMAL FILAMENT. THE SLIT ENTERED THE THERMISTOR LUMEN. IT WAS APPARENT THAT BLOOD LEAKED INTO THE THERMISTOR LUMEN THROUGH THE SLIT AND TRAVELED UP TO THERMISTOR CONNECTOR. A CAPA IS IN PROCESS FOR SLIT IN CATHETER BODY RELATED TO BLOOD LEAKAGE AT THE THERMISTOR CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKAGE WAS OBSERVED FROM THE CONNECTION TO THE CCO CABLE IN ICU AFTER CARDIAC SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 777HF8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other