BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1032172 · Received April 21, 2008

    Report

    Report Number
    1828100-2008-00224
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 21, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE PUMP FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE LOCAL DISPLAY OF THE ROLLER PUMP DID NOT DISPLAY THE INTENDED ALPHANUMERIC CHARACTERS PROPERLY. ALL OF THE SEGMENTS OF THE LED DISPLAY WERE ILLUMINATED. NO PT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1