BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1791536 · Received August 6, 2010

    Report

    Report Number
    1828100-2010-01088
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 6, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT POTASSIUM READINGS AFTER IN VIVO WERE INACCURATE. THE USER ALSO REPORTED UPON DRAWING A SECOND CALIBRATION ELECTROLYTE LEVEL, THE CDI WAS READING 2-4 MMOLE/L. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A 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