BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2802545 · Received October 19, 2012

    Report

    Report Number
    1828100-2012-01320
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    TERUMO CARDIOVASCLUAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS A COMMUNICATION ERROR TO THE ARTERIAL PUMP. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCLUAR SYSTEM CORP 16401

    Patients

    Seq Age Sex Outcome Treatment
    1