BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS 8000 MODULE PERFUSION SYSTEM

    MDR report key: 6984175 · Received October 27, 2017

    Report

    Report Number
    1828100-2017-00491
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Report Date
    October 27, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KRL
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS PER THE FIELD SERVICE REPRESENTATIVE (FSR), THE ABD WAS CLEANED AND THE CONNECTION TO THE SAFETY MONITOR WAS TIGHTENED. 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 AIR BUBBLE DETECTOR (ABD) KEPT ALARMING. 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
    764609 SARNS 8000 MODULE PERFUSION SYSTEM DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM KRL TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 149673

    Patients

    Seq Age Sex Outcome Treatment
    1