BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFURSION SYSTEM 1

    MDR report key: 1181011 · Received September 23, 2008

    Report

    Report Number
    1828100-2008-00447
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 23, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP UNEXPECTEDLY STOPPED WITHOUT AN AUDIBLE ALARM OR WARNING SIGNALS. THE USER WAS ABLE TO RESTART THE ROLLER PUMP AND THE PROCEDURE CONCLUDED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFURSION SYSTEM 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 801763

    Patients

    Seq Age Sex Outcome Treatment
    1