BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2030768 · Received March 4, 2011

    Report

    Report Number
    1828100-2011-00474
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 4, 2011
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE LEVEL SENSOR ALERTED WHILE THERE WERE STILL 3 LITERS OF VOLUME IN THE RESERVOIR. THE USER REGELLED AND PLACED A NEW LEVEL SENSING PAD ON THE RESERVOIR. THE USER REPORTED THAT THE SAME FALSE POSITIVE ALARM OCCURRED DURING THE OPEN HEART PROCEDURE. THE PERFUSIONIST DISCONNECTED THE LEVEL SENSOR FOR THE REMAINDER OF THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 HEART LUNG CONSOLE LEVEL SENSOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195215

    Patients

    Seq Age Sex Outcome Treatment
    1