BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO KHURI MYOCARDIAL PH MONITOR

    MDR report key: 645326 · Received September 28, 2005

    Report

    Report Number
    2023117-2005-00001
    Event Type
    Malfunction
    Date Received
    September 28, 2005
    Date of Event
    August 30, 2005
    Report Date
    September 28, 2005
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    CBZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE MYOCARDIAL PH SENSOR DURING CARDIOPULMONARY BYPASS SURGERY, THE SENSOR EXHIBITED INACCURATE PH VALUES TO AN EXTENT THAT COULD HAVE CAUSED THE SURGEON TO DRAW INCORRECT CONCLUSIONS ABOUT THE STATUS OF THE HEART TISSUE PH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO KHURI MYOCARDIAL PH MONITOR INDWELLING PH SENSOR CBZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 7205 2005-12AW

    Patients

    Seq Age Sex Outcome Treatment
    1 *