BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 3912871 · Received May 14, 2014

    Report

    Report Number
    2523595-2014-00139
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C304 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED. CAPA# (B)(4) ARE ALREADY OPENED TO INVESTIGATE CELLEX DRIVE TUBE LEAKS/BREAKS AND CENTRIFUGE BLOOD LEAK ALARMS, RESPECTIVELY. SERVICE ORDER FEEDBACK HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL WILL BE SUBMITTED ONCE THIS INFORMATION IS RECEIVED. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO ROOT CAUSE CAN YET BE DETERMINED AS THE INVESTIGATION REMAINS ONGOING AT THIS TIME. A SUPPLEMENTAL WITH THE INVESTIGATION FINDINGS WILL BE SUBMITTED ONCE THIS INFORMATION IS RECEIVED. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO ROOT CAUSE CAN YET BE DETERMINED AS THE INVESTIGATION REMAINS ONGOING AT THIS TIME. A SUPPLEMENTAL WITH THE INVESTIGATION FINDINGS WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT DRIVE TUBE LEAK DURING TREATMENT PROCEDURE, 1517 ML WHOLE BLOOD PROCESSED. CUSTOMER STATED THERE WAS A NOISE COMING FROM THE CENTRIFUGE AND WHEN THEY WENT TO INSPECT WHAT HAPPENED, THE BLOOD LEAK ALARM SOUNDED AND BLOOD WAS SPRAYED ALL OVER THE CENTRIFUGE WALL. CSS ASKED IF ANYONE WAS SPLASHED WITH THE BLOOD. CUSTOMER STATED NO, NO ONE WAS SPLASHED WITH BLOOD AS LEAK WAS WITHIN THE CENTRIFUGE AND THE DOOR WAS SECURELY CLOSED. CSS ASKED IF PATIENT WAS OKAY, CUSTOMER STATED YES, PATIENT IS FINE. CSS ASKED CUSTOMER IF THE CENTRIFUGE BOWL WAS INTACT, CUSTOMER STATED YES THE BOWL IS INTACT AND SO IS THE DRIVE TUBE. CUSTOMER STATED THAT THERE SEEMED TO BE A TEAR IN THE DRIVE TUBE. SERVICE ORDER (B)(4) WAS DISPATCHED TO INSPECT/SERVICE THE INSTRUMENT. CUSTOMER RETURNED SMART CARD, DRIVE TUBE AND CENTRIFUGE BOWL FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288392 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS INC. C304-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR