BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS 8000 PERFUSION SYSTEM

    MDR report key: 5489201 · Received March 9, 2016

    Report

    Report Number
    1828100-2016-00165
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Report Date
    March 9, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KRL
    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 #182810-2016-00164. THE FSR REPLACED THE LATCH ASSEMBLY AND PREVENTIVE MAINTENANCE/INSPECTION WAS COMPLETED SUCCESSFULLY. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT PART WAS RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A FOLLOW-UP EMDR WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE (REFER TO EMDR #1828100-2016-00164), HE FOUND THE ULTRASONIC AIR SENSOR (UAS) LATCH ASSEMBLY WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147324 SARNS 8000 PERFUSION SYSTEM DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 KRL TERUMO CARDIOVASCULAR SYSTEMS CORP. 5773

    Patients

    Seq Age Sex Outcome Treatment
    1