BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPGERSIS SYSTEM

    MDR report key: 3964342 · Received June 19, 2014

    Report

    Report Number
    2523595-2014-00164
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW LOT C312 WAS CONDUCTED. THERE WERE NO NON CONFORMANCE RELATED TO THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED; HOWEVER, MFR'S CAPA (B)(4) IS ALREADY IN PROGRESS TO INVESTIGATE PHOTOACTIVATION MODULE LEAKS. SERVICE ORDER (B)(4) COMPLETED: SERVICE ENGINEER CLEANED PHOTOACTIVATION CHAMBER AND LAMP ASSEMBLY. PERFORMED SYSTEM CHECKOUT. NO FURTHER ACTION REQUIRED. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. THE PRODUCT AND THE PHOTO EVAL ARE 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 CALLED TO REPORT A LEAK IN THE PHOTOACTIVATION CHAMBER. CUSTOMER RECEIVED ALARM #8, BLOOD LEAK PHOTOACTIVATION CHAMBER. CUSTOMER STATED THE ALARM OCCURRED DURING REINFUSION AFTER APPROX HALF OF THE TREATED CELLS HAD RETURNED TO THE PT. CUSTOMER FOLLOWED THE TROUBLESHOOTING PROMPTS ON THE DISPLAY AND OPENED UP THE CENTRIFUGE DOOR TO CHECK FOR LEAKS. CUSTOMER STATED BLOOD FLOWED OUT OF THE PHOTOACTIVATION CHAMBER WHEN SHE OPENED IT. CSS RECOMMENDED ABORTING THE TREATMENT AND NOT RETURNING THE REMAINING CELLS. SERVICE ORDER (B)(4) WAS DISPATCHED. PRODUCT WAS RETURNED FOR INVESTIGATION AND PHOTOS WERE PROVIDED BY CUSTOMER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359441 THERAKOS CELLEX PHOTOPGERSIS SYSTEM CELLEX LNR THERAKOS, INC. C312-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR