BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1000566 · Received February 15, 2008

    Report

    Report Number
    1828100-2008-00096
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 15, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, ADJUSTMENT OF THE ROLLER PUMP OCCLUSION WAS REPORTED TO BE DIFFICULT. THERE WAS NO ADVERSE CONSEQUENCE 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