BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 9000

    MDR report key: 1170205 · Received September 11, 2008

    Report

    Report Number
    1828100-2008-00430
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 11, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K871131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED DURING DELIVERY OF CARDIOPLEGIA SOLUTION, THE VOLUME TRACKING FEATURE OF THE PUMP SYSTEM DID NOT FUNCTION. CARDIOPLEGIA WAS DELIVERED BY ALTERNATIVE MEANS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 9000 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 164300

    Patients

    Seq Age Sex Outcome Treatment
    1