BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS 8000 PERFUSION SYSTEM

    MDR report key: 4963209 · Received August 4, 2015

    Report

    Report Number
    1828100-2015-00665
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 14, 2015
    Report Date
    August 4, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWB
    PMA / PMN Number
    K953901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) REMOVED THE OCCLUSION KNOB, CLEANED OCCLUSION KNOB AND THREADED SHAFT, CHECKED FOR BURS, AND FOUND NONE. THE FSR REGREASED OCCLUSION KNOB AND THREADED SHAFT AND RE-INSTALLED. OCCLUDED AND UN-OCCLUDED OCCLUSION MECHANISM AND MECHANISM PASSED INSPECTION. THE FSR PERFORMED CORRECTIVE MAINTENANCE/INSPECTION SUCCESSFULLY. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. 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 PROCEDURE, THE ROLLER PUMP OCCLUSION WAS FROZEN. 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
    511383 SARNS 8000 PERFUSION SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 PERFUSION SYSTEM DWB TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1