BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3922180 · Received May 23, 2014

    Report

    Report Number
    1828100-2014-00474
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) CONFIRMED THE REPORTED ISSUE. THE SCHOTTKY DIODES IN THE SYSTEM BASE WERE DEFECTIVE, CAUSING THE 24V LAMP TO ILLUMINATE WHEN A/C WAS APPLIED. THE FSR REPLACED THE SCHOTTKY DIODE ASSEMBLY IN THE BASE. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT COMPONENT WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE 24 VOLT AMBER INDICATOR WAS ON WHEN IT SHOULD NOT BE. 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
    307324 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16422

    Patients

    Seq Age Sex Outcome Treatment
    1