BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 1734854 · Received June 4, 2010

    Report

    Report Number
    3006425876-2010-00036
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 3, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD WAS LEAKING FROM THE DEVICE THROUGH THE HEMOSTASIS VALVE DURING INSERTION OF THE EDWARDS LIFESCIENCE SWAN GANZ 7 FR CATHETER. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010 FROM THE SALES REPRESENTATIVE STATED THAT THE ANATOMICAL INSERTION SITE WAS RIGHT JUGULAR VEIN. YES, THERAPY WAS DELAYED/INTERRUPTED, BUT THE AMOUNT OF TIME IS UNKNOWN. AS A RESULT, THEY MANAGED WITHOUT REPLACING THE SWAN GANZ CATHETER. THE OUTCOME OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTERNATIONAL INC ZF0012109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EDWARDS LIFESCIENCE SWAN GANZ 7 FR CATHETER