BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1170206 · Received September 11, 2008

    Report

    Report Number
    1828100-2008-00433
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 11, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K940651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE AIR BUBBLE DETECTION SYSTEM CONTINUALLY ALARMED. AN ALTERNATIVE DEVICE WAS EMPLOYED AND THE CASE CONCLUDED WITHOUT INCIDENT. 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 ADVANCED PERFUSION SYSTEM 1 AIR BUBBLE DETECTOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 149892

    Patients

    Seq Age Sex Outcome Treatment
    1