BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 4152311 · Received October 3, 2014

    Report

    Report Number
    2523595-2014-00255
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C335 WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. AT THE TIME OF THE INVESTIGATION, NO TRENDS WERE DETECTED FOR COMPLAINT CATEGORIES, ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) OR FOR DRIVE TUBE LEAK/BREAK. CAPA (B)(4) HAS ALREADY BEEN INITIATED FOR DRIVE TUBE LEAKS/BREAKS. SERVICE ORDER (B)(4) COMPLETED: FIELD ENGINEER CLEANED THE CENTRIFUGE AND PERFORMED CHECKOUT PROCEDURE PER DOCUMENTATION. CALIBRATED PRESSURE TRANSDUCER. ALL PASSED AND WERE IN ANALOG SPECIFICATION. CALIBRATED LOAD CELLS. FOUND A RUB ON LOAD CELL AND ADJUSTED TO FIX. ALL TESTS PASSED AND ARE IN SPECIFICATION PER DOCUMENTATION. FOUND TOP BEARING CLIP ON CENTRIFUGE WAS LOOSE AND RATTLING. REPLACED CLIP AND TESTED. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. ANALYSIS OF THE RETURNED PRODUCT IS STILL IN PROGRESS AT THE TIME OF THIS REPORT; THEREFORE, FINAL INVESTIGATION FINDINGS ARE STILL PENDING. A SUPPLEMENTAL REPORT WILL BE SENT WHEN THIS INFORMATION IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLOOD LEAK ALARM OCCURRED AT 150 ML WHOLE BLOOD PROCESSED, AND THE TREATMENT WAS THEN ABORTED WITHOUT RETURNING THE BLOOD TO THE PATIENT. CUSTOMER STATED THERE WAS A FINE SPRAY IN THE CENTRIFUGE THAT WAS DIFFICULT TO SEE. CUSTOMER STATED THE EXACT LOCATION OF THE LEAK COULD NOT BE DETERMINED, BUT IT SEEMED TO BE FROM THE DRIVE TUBE, AS THE DRIVE TUBE APPEARED TO BE RED. CUSTOMER REPORTED THE LOWER DRIVE TUBE BEARING SEEMED TO HAVE BROKEN INTO SEPARATE PIECES, ALTHOUGH THE DRIVE TUBE DID NOT APPEAR TO BE BROKEN. CUSTOMER REPORTED THE LOWER BEARING RETAINER WAS STILL CLOSED WHEN THE TREATMENT WAS ABORTED. CUSTOMER DID NOT OBSERVE ANY DAMAGE TO THE CENTRIFUGE LEAK SENSOR STRIP OR TO THE REST OF THE INSTRUMENT, BUT REQUESTED SERVICE BE DISPATCHED TO THOROUGHLY CLEAN THE INSTRUMENT. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER RETURNED THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617351 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS, INC. C335-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR