BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4172843 · Received October 10, 2014

    Report

    Report Number
    2523595-2014-00272
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW OF LOT C336 WAS CONDUCTED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, TUBING LEAK. NO TREND WAS DETECTED FOR THE COMPLAINT CATEGORY, TUBING LEAK. TUBING LEAK WAS INVESTIGATED THROUGH CAPA (B)(4). CAPA (B)(4) WAS CLOSED AS EFFECTIVE. FEEDBACK FOR SERVICE ORDER, (B)(4). THE SERVICE TECH CLEANED UP THE BLOOD LEAK. THE SERVICE TECH REMOVED THE PUMP HEADS AND FOUND MORE BLOOD AND THEN CLEANED AGAIN. THE SERVICE TECH ALSO LUBES THE PUMP HEADS AND REINSTALLED THEM. THE SYSTEM CHECKOUT PROCEDURE WAS THEN SUCCESSFULLY PERFORMED. SERVICE ORDER (B)(4) IS NOW CLOSED AND NO FURTHER ACTION IS REQUIRED. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFO PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A BLOOD LEAK IN THE COLLECT PUMP TUBING. THE CUSTOMER NOTICED A POOL OF BLOOD AROUND THE COLLECT PUMP AND IT WAS SPREADING TO THE RECIRCULATION PUMP AFTER 145 ML WHOLE BLOOD PROCESSED. THE TREATMENT WAS ABORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. A SERVICE ORDER, (B)(4), WAS GENERATED TO CLEAN AND INSPECT THE PUMPS. NO PRODUCT WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642964 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C336-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR