BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1981596 · Received January 31, 2011

    Report

    Report Number
    1828100-2011-00085
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 31, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER OBSERVED A HEMATOCRIT SATURATION COLOR CHIP FAILURE. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 500 BLOOD PARAMETER MONITOR ONLINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1