BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS SYSTEM

    MDR report key: 3915381 · Received May 28, 2014

    Report

    Report Number
    2523595-2014-00148
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C710 WAS CONDUCTED. THERE WERE NO NONCONFORMITIES RELATED TO THIS TYPE OF EVENT FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED; HOWEVER, MANUFACTURER'S CAPA ((B)(4)) HAS ALREADY BEEN INITIATED TO INVESTIGATE CENTRIFUGE BOWL LEAKS/BREAKS. SERVICE ORDER (B)(4) FEEDBACK STILL PENDING. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT HAS RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SYSTEM OCCLUSION ALARMS OCCURRED AS CYCLE 1 BUFFY COLLECT PHASE WAS STARTING. NO KINKED OR PINCHED LINES WERE SEEN. NO CLOTTING WAS SEEN. CUSTOMER TRIED TO DELIVER A SALINE BOLUS, BUT GOT A PATIENT OCCLUSION ALARM, SO SHE DISCONNECTED THE PATIENT, AND THEN DELIVERED A SALINE BOLUS TO A WASTE RECEPTACLE. CUSTOMER RECONNECTED PATIENT AND RESUMED THE TREATMENT, BUT SYSTEM OCCLUSION ALARM RETURNED. CUSTOMER REPORTED ACCESS DEVICE IS A VORTEX PORT. CUSTOMER STATED ANTICOAGULANT IS 10,000 UNITS OF HEPARIN IN 500 ML NORMAL SALINE, AT A 10:1 AC RATIO. A BLOOD LEAK ALARM THEN OCCURRED, WITH CONDENSATION VISIBLE UNDER THE CENTRIFUGE COVER. THE TREATMENT WAS ABORTED WITHOUT RETURNING THE BLOOD TO THE PATIENT. AFTER THE TREATMENT WAS ABORTED, A FIELD ENGINEER ADVISED CSS THAT AIR WAS COMING OUT OF ONE OF THE VENTS IN THE BLOOD PUMP MEMBRANE. CSS ADVISED ENGINEER THE BLOOD PUMP MUST BE REPLACED. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER WILL RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314787 THERAKOS XTS SYSTEM LNR THERAKOS, INC. C710-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR