BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 4202629 · Received September 18, 2014

    Report

    Report Number
    2523595-2014-00246
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C307 WAS PERFORMED AND THERE WAS ONE NON-CONFORMANCE ASSOCIATED WITH THIS LOT. INC16137 WAS INITIATED FOR DRIVE TUBE DELAMINATION. MANUFACTURING PROCEDURE BOUNDS THE FAILURE BY ADDITIONAL TESTING OF PROCEDURAL KITS WHERE THE FAILURE HAS OCCURRED. THE LOT MET RELEASE REQUIREMENTS. AT THE TIME OF THE INVESTIGATION, NO TRENDS WERE DETECTED FOR COMPLAINT CATEGORIES, DRIVE TUBE LEAK/BREAK OR CENTRIFUGE LEAK/BREAK. CAPA (B)(4) HAS BEEN INITIATED FOR DRIVE TUBE LEAKS/BREAKS. CAPA (B)(4) HAS BEEN INITIATED FOR CENTRIFUGE BOWL FAILURES. SERVICE ORDER (B)(4) COMPLETED: FIELD ENGINEER CLEANED THE INSTRUMENT. CENTRIFUGE BOWL WAS FOUND BROKEN. REPLACED CENTRIFUGE LEAK DETECTOR STRIP AND FIXED CENTRIFUGE BEARING CLIP. RAN SYSTEM CHECKOUT. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT TH TIME OF THE INVESTIGATION. ANALYSIS OF THE PHOTOS SENT BY THE CUSTOMER 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 REPORTED A BLOOD LEAK OCCURRED IN THE CENTRIFUGE NEAR THE END OF THE INITIAL PURGING AIR PHASE, AT APPROXIMATELY 200 ML WHOLE BLOOD PROCESSED. CUSTOMER STATED THE SINGLE NEEDLE MODE TREATMENT WAS ABORTED AND THE BLOOD IN THE KIT WAS NOT RETURNED TO THE PATIENT. CUSTOMER STATED THE PATIENT WAS BEING GIVEN SALINE PER PHYSICIAN'S ORDER AFTER THE TREATMENT WAS ABORTED. CUSTOMER STATED THE BOWL HAD BROKEN INTO PIECES AND PROVIDED TWO PHOTOS OF THE BROKEN BOWL IN THE CENTRIFUGE. CUSTOMER STATED THE BOWL HAD BEEN LOCKED SECURELY INTO THE BOWL HOLDER AND HAD BEEN CHECKED CAREFULLY. SERVICE WAS DISPATCHED TO REPLACE THE LEAK SENSOR STRIP AND TO CLEAN AND CHECK OUT THE INSTRUMENT. THE KIT WAS INADVERTENTLY DISCARDED AND IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580856 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS, INC. C307 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR