BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1062292 · Received June 18, 2008

    Report

    Report Number
    1828100-2008-00308
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 18, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP DISPLAY DID NOT DISPLAY IMAGES AS EXPECTED. PUMP STATUS CONTINUED TO BE AVAILABLE BY MEANS OF THE CENTRAL CONTROL MONITOR. CONTROL OF THE PUMP SPEED REMAINED AVAILABLE THROUGH THE LOCAL SPEED CONTROL KNOB AND THE CENTRAL CONTROL MONITOR OF THE HEART LUNG CONSOLE. 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. 801040

    Patients

    Seq Age Sex Outcome Treatment
    1