BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3915762 · Received June 12, 2014

    Report

    Report Number
    1828100-2014-00468
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED BY A PHOTOGRAPH. THE USER FACILITY'S BIOMEDICAL DEPARTMENT (BIOMED) IS GOING TO REPLACE THE LATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE LATCH ON VENOUS OCCLUDER LID WAS BROKEN. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346552 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16418

    Patients

    Seq Age Sex Outcome Treatment
    1