BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2182794 · Received July 8, 2011

    Report

    Report Number
    1828100-2011-01960
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 8, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE GAS READINGS FROM THE LAB (PARTIAL PRESSURE OF OXYGEN (PO2) AND HEMATOCRIT) WERE MUCH LOWER THAN WHAT THE MONITOR WAS READING. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE 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 ON LINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEM CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1