BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2182552 · Received July 11, 2011

    Report

    Report Number
    1828100-2011-01933
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 11, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE ROLLER PUMP MADE A RUBBING NOISE. MAYBE THE FAN. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1