BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1840649 · Received September 17, 2010

    Report

    Report Number
    1828100-2010-01430
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 17, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE ON THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE FLOW METER DISPLAYED A "?" FOR THE L/MIN FLOW READING. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 FLOW MODULE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802018

    Patients

    Seq Age Sex Outcome Treatment
    1