BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1935819 · Received December 3, 2010

    Report

    Report Number
    1828100-2010-02365
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 2, 2010
    Report Date
    December 3, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED HEARING A NOISE FROM THE ROLLER PUMP. THE USER REPORTED AFTER RELOADING THE TUBING INTO THE TUBE CLAMP AND RESTARTING THE ROLLER PUMP, THE NOISE DISAPPEARED. THE DEVICE WAS USED TO CONCLUDE THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816571

    Patients

    Seq Age Sex Outcome Treatment
    1