BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1182302 · Received September 30, 2008

    Report

    Report Number
    1828100-2008-00459
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 30, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE A CARDIOPULMONARY BYPASS PROCEDURE, A FAILED POWER SUPPLY WAS OBSERVED. THE HEART LUNG CONSOLE IS FULLY FUNCTIONAL WITH ONE OF THE TWO POWER SUPPLIES OPERATING, HOWEVER, WITHOUT THE SECOND POWER SUPPLY, THE BACKUP BATTERY POWER SOURCE CANNOT BE RECHARGED. 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 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 801763

    Patients

    Seq Age Sex Outcome Treatment
    1