BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 4152310 · Received October 3, 2014

    Report

    Report Number
    2523595-2014-00260
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF C721 WAS PERFORMED AND THERE WAS ONE NONCONFORMANCE ASSOCIATED WITH THIS LOT. HOWEVER, THE NC WAS NOT RELATED TO THE NATURE OF THIS COMPLAINT. THIS LOT MET RELEASE REQUIREMENTS. A REVIEW OF LOT C721 SHOWS NO TRENDS FOR THESE COMPLAINT CATEGORIES. A REVIEW OF THE COMPLAINT CATEGORIES SHOWS NO TRENDS FOR CENTRIFUGE BOWL LEAK/BREAK OR OCCLUSION SYSTEM ALARM. HARMAC SCAR 143 WAS INITIATED FOR COMPLAINT CATEGORY CENTRIFUGE BOWL LEAK/BREAK. THE PRODUCT WAS NOT RETURNED FOR FURTHER ANALYSIS; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATIONS. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT SYSTEM OCCLUSION ALARM DURING COLLECT/DRAW PHASE OF CYCLE 2. CUSTOMER STATED SHE USED TPA PRIOR TO THE START OF TREATMENT AND ALSO FLUSHED THE ACCESS LINE WHICH IS WORKING FINE. CUSTOMER WAS ASKED TO CHECK ALL PARTS OF THE KIT FOR ANY CLOTTING OR OCCLUSIONS. CUSTOMER CHECKED KIT BUT DID NOT SEE ANY CLOTTING OR OCCLUSIONS. CUSTOMER WAS ASKED TO RUN A SALINE BOLUS INTO A SEPARATE RECEPTACLE BY DISCONNECTING THE COLLECT LINE FROM THE ACCESS LINE. CUSTOMER DID SO. CUSTOMER RESTARTED THE PROCEDURE BUT ALARM CONTINUED TO OCCUR. CUSTOMER WAS ASKED TO PRESS STOP AND POWER THE INSTRUMENT OFF. CUSTOMER DID SO. CUSTOMER WAS ASKED TO OPEN ANY CLOTTING OR OCCLUSIONS. UPON REMOVING THE CENTRIFUGE BOWL, CUSTOMER NOTED THERE WAS BLOOD LEAKING FROM THE NECK OF THE BOWL. CSS ASKED IF THERE WAS ANY CLOTTING OR OCCLUSIONS IN THE BOWL, CUSTOMER STATED THERE WAS NO CLOTTING OR OCCLUSIONS IN THE BOWL. CUSTOMER WAS ASKED TO ABORT THE TREATMENT PROCEDURE WITH NO RETURN OF BLOOD/PRODUCTS TO THE PATIENT. NO PRODUCT WAS RETURNED FOR EVALUATION. NO SERVICE ORDER WAS DISPATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617276 THERAKOS XTS PHOTOPHERESIS SYSTEM XTS LNR THERAKOS, INC. C721 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR