BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM ONE

    MDR report key: 1022219 · Received March 26, 2008

    Report

    Report Number
    1828100-2008-00174
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT. EVALUATION IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE LEVEL SENSOR GAVE A FALSE LOW LEVEL ALERT. THE SENSOR WAS REPLACED. 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 PERFUSION SYSTEM ONE HEART LUNG CONSOLE (BLOOD LEVEL SENSOR) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195215

    Patients

    Seq Age Sex Outcome Treatment
    1