BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1012797 · Received March 12, 2008

    Report

    Report Number
    1828100-2008-00177
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 7, 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
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE PUMP SYSTEM FOR CARDIOPULMONARY BYPASS, THE ROLLER PUMP ISSUED AN UNUSUAL SOUND AND MOMENTARILY STOPPED OPERATING. THE SYSTEM WAS SUCCESSFULLY RESTARTED BY THE USER. 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 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 801040

    Patients

    Seq Age Sex Outcome Treatment
    1