BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSDUCER LINE SET-TRIPLE SET

    MDR report key: 1152087 · Received September 4, 2008

    Report

    Report Number
    MW5008234
    Event Type
    Other
    Date Received
    September 4, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES CORP.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS LEAKING FLUID BETWEEN WHITE SPIKE AND CLEAR DRIP CHAMBER. THE PT WAS ADMITTED IN ICU AFTER AN ABORTED ATTEMPT TO REPLACE HER MITRAL VALVE. ONE OF THE PROBLEMS REPORTED FROM THE OR TEAM WAS HYPOTENSION. THE INVASIVE MONITORING LINES ATTACHED TO HER RIGHT RADIAL LINE, PA AND CVP LINE WAS NOTED TO BE LEAKING AROUND THE DRIP CHAMBER WHERE THE WHITE SPIKE IS ATTACHED TO THE CLEAR DRIP CHAMBER. THIS COULD POTENTIALLY RESULT IN INACCURATE READINGS. WHEN THE FEMORAL ARTERIAL LINE PRESSURE WAS INITIALLY COMPARED TO THE RADIAL LINE THE FEMORAL LINE WAS HIGHER AND HAD A BETTER WAVE FORM. THE LINES WERE CHANGED AND ACCURATE READINGS WERE ONCE AGAIN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSDUCER LINE SET-TRIPLE SET TRANSDUCER DRS EDWARDS LIFESCIENCES CORP. REF# PXMK133

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other