BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3102529 · Received May 2, 2013

    Report

    Report Number
    1828100-2013-00417
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP WAS BEING USED AS A "SUCKER" PUMP, THE SPEED WAS DECREASED TO FLOW RATE NEAR 50 CC/MINUTE. THE PUMP WAS OBSERVED TO HAVE A "JERKY" STOP/START ROTATION. THE DEVICE WAS NOT CHARGED OUT, AS THE USER INCREASED SPEED TO ALLEVIATE PROBLEM. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193411 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1