BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3915388 · Received May 28, 2014

    Report

    Report Number
    2523595-2014-00149
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C305 WAS CONDUCTED. THERE WERE NO NONCONFORMITIES RELATED TO THIS TYPE OF EVENT FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR TUBING LEAK COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED; CAPA (B)(4) WAS OPENED TO INVESTIGATE THESE TYPES OF FAILURES. A TREND WAS DETECTED FOR TUBING LENGTH COMPLAINT CATEGORY, AND CAPA (B)(4) IS CURRENTLY OPEN TO INVESTIGATE EVENTS RELATED TO THIS TYPE OF FAILURE. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BLOOD LEAK AT THE START OF PHOTOACTIVATION THAT THE RECIRCULATION PUMP TUBING. PROCEDURE WENT WELL UNTIL THE OPERATOR NOTICED BLOOD LEAKING FROM THE RECIRCULATION PUMP TUBING SEGMENT. TREATMENT WAS ABORTED. PATIENT WAS SET UP ON ANOTHER INSTRUMENT. OPERATORS WERE ABLE TO REMOVE THE PUMP AND CLEAN UNDERNEATH IT. CUSTOMER DOES NOT NEED SERVICE AT THIS TIME. CSS ASKED IF DURING INSTALLATION, THE RECIRCULATION PUMP TUBING SEGMENT SEEMED TOO TIGHT OR TOO LOOSE. CUSTOMER STATED IT WAS TOO LOOSE, BUT SHE WAS EVENTUALLY ABLE TO LOAD IT. CUSTOMER STATES SHE RECEIVED PRIME 11 ALARM X1, RESET IT, AND COMPLETED PRIME. CUSTOMER STATED SHE DID NOT SEE ANY LEAKS OR KINKS AND PROCEEDED WITH TREATMENT. CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314505 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C305-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR