BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1853817 · Received September 3, 2010

    Report

    Report Number
    1828100-2010-01292
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    March 1, 2010
    Report Date
    September 4, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE LEVEL SENSOR HAD BROKEN WIRES. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND 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 PERFUSION SYSTEM 8000 HEART LUNG CONSOLE LEVEL SENSOR JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 195274

    Patients

    Seq Age Sex Outcome Treatment
    1