BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2982767 · Received February 25, 2013

    Report

    Report Number
    1828100-2013-00168
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 4, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS DETERMINING IF THEY ARE SENDING THE SUSPECT UNIT IN FOR REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE TUBE GUIDE WAS BROKEN ON THE ROLLER PUMP. THE PIECE OF METAL WHERE IT PINS IN WAS BROKEN OFF. THE DEVICE WAS NOT CHANGED OUT, AS THE UNIT FUNCTIONS AND WERE ABLE TO FINISH THE CASE WITH THE UNIT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79153 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1