BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2182626 · Received July 5, 2011

    Report

    Report Number
    1828100-2011-01906
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    JUST PRIOR TO THE ONSET OF CARDIOPULMONARY BYPASS, THE USER REPORTED THAT THE ARTERIAL TEMPERATURE WAS +2-3 DEGREES INACCURATE ON THE VENOUS SIDE, EVEN THOUGH THEY WERE JUST RECIRCULATING. THE DEVICE WAS NOT CHANGED OUT. 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 SYSTEM CORP 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1