BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1012795 · Received March 12, 2008

    Report

    Report Number
    1828100-2008-00179
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 12, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PUMP SYSTEM LOST AC POWER. AN ALTERNATE DEVICE WAS EMPLOYED. THE USER DISCOVERED THAT THE USER FACILITY AC OUTLET THAT THE PUMP SYSTEM HAD BEEN PLUGGED INTO WAS NOT RELIABLE. 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