BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2211821 · Received August 10, 2011

    Report

    Report Number
    1828100-2011-02397
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 10, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORT THAT THE HEMATOCRIT SATURATION PROBE DID NOT FUNCTION AS EXPECTED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND 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 CDI 500 BLOOD PARAMETER MONITOR ON LINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1