BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 101 MONITOR

    MDR report key: 2030820 · Received March 4, 2011

    Report

    Report Number
    1828100-2011-00471
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 20, 2011
    Report Date
    March 4, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PRIMING OF THE DEVICE IN PREPARATION FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE UNIT FAILED TO READ PARAMETERS AND THAT A "COLOR CHIP" ERROR MESSAGE OCCURRED. A VERY TIGHT INTERFACE CABLE CONNECTION WAS ALSO NOTED. THE DEVICE WAS NOT CHANGED OUT FOR THE PROCEDURE. 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 101 MONITOR MONITOR DTY TERUMO CARDIOVASCULAR SYSTEMS CORP 101

    Patients

    Seq Age Sex Outcome Treatment
    1