BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1925875 · Received November 8, 2010

    Report

    Report Number
    1828100-2010-02032
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 8, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE ROLLER PUMP DID NOT FUNCTION AS EXPECTED. THE USER REPORTED THAT WHEN THE ARTERIAL PUMP HEAD WAS STOPPED WITH THE ROLLERS IN THE 10 O'CLOCK AND 4 O'CLOCK POSITIONS, THE PUMP WOULD DRIFT BACK APPROX 1/16 OF A REVOLUTION BEFORE COMING TO A STOP. 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 PT 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. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1