BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS SYSTEM

    MDR report key: 4121536 · Received July 29, 2014

    Report

    Report Number
    2523595-2014-00196
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C712 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TRENDS HAVE BEEN DETECTED FOR DRIVE TUBE LEAK/ BREAKS; MANUFACTURER'S CAPA ((B)(4)) IS ALREADY OPENED TO INVESTIGATE CENTRIFUGE BOWL LEAK/BREAKS. SERVICE ORDER (B)(4) FEEDBACK IS STILL PENDING. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. THE PHOTO EVALUATION IS STILL IN PROGRESS AT THE TIME OF THIS REPORT; THEREFORE, FINAL INVESTIGATION FINDINGS ARE STILL PENDING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED BLOOD LEAK ALARM AFTER START OF THE FIRST CYCLE. CUSTOMER FOUND A LEAK AT THE BOTTOM OF THE BOWL. CUSTOMER TRIED TO PUT OUT THE BLOOD OUT OF THE CENTRIFUGE CHAMBER. PHYSICIAN TOOK PHOTOS OF THE DAMAGED BOWL AND WILL SEND FOR INVESTIGATION. CUSTOMER ASKED FOR SERVICE TO CHECK THE MACHINE AFTER THE LEAK. TREATMENT WAS ABORTED AND WILL BE DONE NEXT DAY. PATIENT INFO: PLATELET COUNT: 258000, AC: BEFORE TREATMENT: 500 I.U. HEPARIN IN 5ML SALINE INJECTION, 10000 I.U. HEPARIN IN 500 ML SALINE, RATIO 10:1. ACCESS: PAKUMED-PORT, PORT NEEDLE 17G. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER PROVIDED PHOTOS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442823 THERAKOS XTS SYSTEM XTS LNR THERAKOS, INC. C712-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 R.N.P.