BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2101969 · Received May 18, 2011

    Report

    Report Number
    1828100-2011-01600
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 18, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE ARTERIAL MODULE WAS NOT WORKING, AND THAT THE PARAMETER VALUES FROM THE MONITOR WERE NOT ACCURATE AS PER LAB RESULTS. THE PROCEDURE CONTINUED WITHOUT THE DEVICE BEING 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. 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1