BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3070225 · Received April 16, 2013

    Report

    Report Number
    1828100-2013-00404
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 25, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS GOING TO REPLACE THE GUT ASSEMBLY ON THE ROLLER PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER TO ROLLER OCCLUSION WOULD NOT REMAIN STEADY. EVEN AFTER ADJUSTING THE OCCLUSION WITH THE DIAL INDICATOR AFTER ONE OR TWO DAYS IT SHIFTS. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. 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
    164015 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16407

    Patients

    Seq Age Sex Outcome Treatment
    1