BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1222909 · Received November 6, 2008

    Report

    Report Number
    1828100-2008-00537
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAIN ROLLER PUMP SLOWED DOWN AND IS STARTING AND STOPPING A LOT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT REPORTED AS A RESULT OF THIS EVENT NOTE: THE DATE OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1