BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3813203 · Received March 26, 2014

    Report

    Report Number
    1828100-2014-00210
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Report Date
    March 3, 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

    CUSTOMER HAS ORDERED A REPLACEMENT LEVEL DETECTOR FOR REPAIRS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CARDIOPULMONARY BYPASS OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE LEVEL DETECTOR WAS NOT WORKING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176895 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 195258

    Patients

    Seq Age Sex Outcome Treatment
    1