BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 101 MONITOR

    MDR report key: 1992897 · Received February 4, 2011

    Report

    Report Number
    1828100-2011-00131
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 4, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 REPORTED, THE DARK GREY/BEIGE PART TIP WAS BROKEN WHERE IT LOCKS INTO THE CUVETTE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO 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 101 MONITOR INTERFACE MODULE DTY TERUMO CARDIOVASCULAR SYSTEMS CORP. 7101

    Patients

    Seq Age Sex Outcome Treatment
    1