BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1723648 · Received June 9, 2010

    Report

    Report Number
    1828100-2010-00511
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 9, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE OCCLUSION KNOB ON THE ROLLER PUMP FROZE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 ROLLER PUMP JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1