BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS 8000 PERFUSION SYSTEM

    MDR report key: 5489189 · Received March 9, 2016

    Report

    Report Number
    1828100-2016-00164
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    February 16, 2016
    Report Date
    April 6, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTW
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS COMPLAINT IS RELATED TO EMDR #182810-2016-00165. THE FIELD SERVICE REPRESENTATIVE (FSR) WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. AFTER DISCUSSING THE ISSUE WITH THE CCP, HE THOUGHT THAT PERHAPS THEY (THE STUDENTS) MAY NOT HAVE CONNECTED THE ULTRASONIC AIR SENSOR (UAS) PROPERLY. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. NO PART WILL BE RETURNED FOR EVALUATION. 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

    ADDITIONAL INFORMATION: AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY BLOOD LOSS AS A RESULT OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PERFUSIONIST (CCP) CLAIMS THAT THE AIR BUBBLE DETECTOR (ABD) CONNECTOR WAS NOT MAKING PROPER CONNECTION WITH AIR SENSOR CABLE ON THE SAFETY MONITOR. 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
    147303 SARNS 8000 PERFUSION SYSTEM MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS-SARNS 8000 DTW TERUMO CARDIOVASCULAR SYSTEMS CORP. 16404

    Patients

    Seq Age Sex Outcome Treatment
    1