BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1082615 · Received July 23, 2008

    Report

    Report Number
    1828100-2008-00357
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 23, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRIFUGAL PUMP FLOW SENSOR DISPLAYED A "BACKFLOW" ERROR MESSAGE EVEN THOUGH THE CIRCUIT TUBING WAS CLAMPED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL PUMP FLOW SENSOR KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 6382

    Patients

    Seq Age Sex Outcome Treatment
    1