BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2102496 · Received May 20, 2011

    Report

    Report Number
    1828100-2011-01374
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 20, 2011
    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

    Description of Event or Problem · 1

    JUST PRIOR TO THE ONSET OF CARDIOPULMONARY BYPASS, THE USER REPORTED THAT THE PUMP HEAD EXHIBITED VIBRATION AND NOISE. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES 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 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 816571

    Patients

    Seq Age Sex Outcome Treatment
    1