BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEWAVE TRANSDUCER/VAMP COMBINATION KIT

    MDR report key: 1060973 · Received June 12, 2008

    Report

    Report Number
    6000002-2007-05040
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    July 8, 2007
    Report Date
    August 10, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VAMP ARTERIAL PRESSURE TUBING ATTACHED TO THE RIGHT FEMORAL SHEATH (DEFECTIVE CONNECTION) DETACHED CAUSING ARTERIAL BLOOD LOSS. REPORTEDLY, THE NURSE OBSERVED THE EVENT IMMEDIATELY. IT WAS FURTHER REPORTED THAT THE TUBING WAS REPLACED. THERE WERE NO PT COMPLICATIONS REPORTED. IT WAS REPORTED THAT THE PT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUEWAVE TRANSDUCER/VAMP COMBINATION KIT VENOUS ARTERIAL BLOOD MANAGMENT PROTECTION SYSTEM DRS EDWARDS LIFESCIENCES PXVK064 58291264

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention