BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 4202579 · Received September 18, 2014

    Report

    Report Number
    1828100-2014-00752
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) ORDERED A NEW CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) TO REPAIR THE MONITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, WHEN SETTING UP THE SYSTEM THE NIGHT BEFORE SURGERY, THE USER NOTICED THE CARDIOPLEGIA MONITOR WAS DISPLAYING "PPPPPP'S" ACROSS THE UPPER DISPLAY AND "GEL" IN THE LOWER DISPLAYS. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580759 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 16414

    Patients

    Seq Age Sex Outcome Treatment
    1