BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS 8000 PERFUSION SYSTEM

    MDR report key: 6908019 · Received October 2, 2017

    Report

    Report Number
    1828100-2017-00446
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 7, 2017
    Report Date
    December 18, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWA
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS PER THE SUBSIDIARY, TUBING WAS USED DURING CALIBRATION AND THE ERROR OCCURED WHEN THE DEVICE WAS IN THE FULLY OCCLUDE POSITION.

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 1

    DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) ATTACHED A LABORATORY USE OCCLUDER HEAD TO THE RETURNED OCCLUDER AND IT WAS ABLE TO FULLY OCCLUDED.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE SERVICE REPAIR TECHNICIAN (SRT) ATTACHED THE OCCLUDER TO THE SERVICE DEPOT TEST EQUIPMENT AND THE COMPLAINT WAS NOT DUPLICATED. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE VENOUS LINE OCCLUDER WAS UNABLE TO FULLY OCCLUDE THE TUBING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687225 SARNS 8000 PERFUSION SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM DWA TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 16418

    Patients

    Seq Age Sex Outcome Treatment
    1