BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2091562 · Received April 6, 2011

    Report

    Report Number
    1828100-2011-01072
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 6, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PRIMING OF THE DEVICE IN PREPARATION FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE AIR SENSOR GENERATED AN AUDIBLE ALARM WHEN THERE WAS NO ERROR PRESENT. AS RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 AIR BUBBLE DETECTOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 5773

    Patients

    Seq Age Sex Outcome Treatment
    1