BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTPHERESIS SYSTEM

    MDR report key: 4651116 · Received March 27, 2015

    Report

    Report Number
    2523595-2015-00088
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 19, 2015
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C365 WAS CONDUCTED, THERE WERE NO NONCONFORMANCE'S RELATED TO THIS COMPLAINT. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR ALL COMPLAINT CATEGORIES AND NO TREND WAS DETECTED FOR CENTRIFUGE BOWL LEAK/BREAK NOR FOR ALARM #17: RETURN PRESSURE. CAPA (B)(4) WAS INITIATED FOR CENTRIFUGE BOWL LEAK/BREAKS AND CAPA (B)(4) WAS INITIATED FOR ALARM #17: RETURN PRESSURE; CAPA (B)(4) IS NOW CLOSED. AN UPWARD TREND WAS OBSERVED FOR ALARM #45: RED BLOOD CELL PUMP ALARM; CAPAP (B)(4) AND CAPA (B)(4) WERE INITIATED FOR ALARM #45: RED BLOOD CELL PUMP ALARM AND ARE NOW CLOSED. SVC ORDER SRV-(B)(4) WAS COMPLETED: SVC ENGINEER CLEANED THE INSTRUMENT, REPLACED DAMAGED LEAK STRIP AND IR COMPRESSOR FUSE. PERFORMED SUCCESSFULLY THE SYS CHECKOUT TEST AND RETURNED THE INSTRUMENT TO SVC. THE PRODUCT RETURN INVESTIGATION IS STILL IN PROGRESS AT THE TIME OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THIS INVESTIGATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SMART CARD DATA AND KIT COMPONENTS (BOWL PIECES & DRIVE TUBE) WERE RETURNED FOR ANALYSIS. REVIEW OF THE SMARTCARD DATA INDICATED SEVERAL RETURN PRESSURE WARNINGS, RED CELL PUMP ALARM AND BLOOD PUMP ERROR WARNINGS WERE SEEN. BASED ON THE REVIEW OF PHOTOS AND THE RETURNED SAMPLE, IT WAS CONFIRMED THAT THE BOWL WAS BROKEN. THE VISUAL EXAMINATION OF THE RETURNED PARTS INDICATED BOTH BEARING STOPS ARE FIRMLY ATTACHED TO THE DRIVE TUBE AND DO NOT SHOW ANY WEAR OR DELAMINATION. THE MOST LIKELY CAUSE OF THE BOWL BREAK WAS A BREAK IN THE OUTER BOWL THROUGH THE BOWL WALL AND COVER. HOWEVER, IT COULD NOT BE DETERMINED WHAT CAUSED THIS FAILURE. NO MANUFACTURING DEFECT COULD BE DETERMINED. THE DHR REVIEW OF THE COMPLAINT LOT FOUND NO RELATED NONCONFORMANCES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6)-2015 TO REPORT CENTRIFUGE BOWL BREAK DURING PROCEDURE ON (B)(6)-2015. CUSTOMER STATED AT 1300 ML WHOLE BLOOD PROCESSED, END USER HEARD A CLICKING NOISE THEN THE BOWL SHATTERED. CUSTOMER ALSO REPORTED THA THE LEAK DETECTOR STRIP WAS DAMAGED. CUSTOMER REPORTED PT WAS STABLE AND THEY WERE ABLE TO TREAT PT ON A SECOND INSTRUMENT SUCCESSFULLY. CSS ASKED IF THERE WAS ANYTHING REMARKABLE ABOUT THE KIT PRIOR TO LOADING IT, CUSTOMER STATED THERE WAS NOTHING REMARKABLE OBSERVED ABOUT THE KIT. CSS ASKED IF THERE WERE ANY ALARMS DURING PRIME. CSS ASKED IF THERE WERE ANY ALARMS DURING TREATMENT PROCEDURE, CUSTOMER STATED THERE WERE A FEW RED BLOOD CELL PUMP ALARMS AND RETURN PRESSURE ALARMS DURING THE TREATMENT PROCEDURE. SVC WAS DISPATCHED (SRV-(B)(4)) PER CUSTOMER'S REQUEST. CUSTOMER AGREED TO RETURN KIT/SMART CARD FOR INVESTIGATION, AND ALSO OFFERED TO SEND PICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205282 THERAKOS CELLEX PHOTPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C365-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR