BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1052957 · Received May 27, 2008

    Report

    Report Number
    1828100-2008-00281
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 27, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, A WARNING LIGHT INDICATING THAT BATTERY BACKUP MAY NOT BE AVAILABLE WAS OBSERVED. THE POWER MANAGER PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED, RESTORING THE DEVICE TO NORMAL FUNCTION. THERE WAS NO ADVERSE CONSEQUENCE TO A PT 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