BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4152312 · Received October 3, 2014

    Report

    Report Number
    2523595-2014-00252
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C122 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PRESSURE DOME MEMBRANE LEAK. NO TREND WAS DETECTED FOR COMPLAINT CATEGORY, PRESSURE DOME MEMBRANE LEAK. CAPA (B)(4) WERE INITIATED FOR COMPLAINT CATEGORY, PRESSURE DOME MEMBRANE LEAK. SERVICE ORDER, (B)(4), FEEDBACK: THE SERVICE ORDER TECHNICIAN REPLACED AND CALIBRATED THE PRESSURE TRANSDUCER, CLEANED UP THE BLOOD, AND RAN A SYSTEM CHECKOUT. SERVICE ORDER (B)(4) IS NOW CLOSED AND NO FURTHER ACTION IS REQUIRED. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. PRODUCT ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THIS ANALYSIS IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A BLOOD LEAK WAS OBSERVED AT THE SYSTEM PRESSURE DOME WHEN THE SINGLE NEEDLE MODE TREATMENT HAD REACHED 262 ML WHOLE BLOOD PROCESSED. NO ALARMS OCCURRED. THE TREATMENT WAS ABORTED AT THAT TIME AND THE BLOOD IN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER STATED THEY WERE STARTING A NEW ECP TREATMENT FOR THE PATIENT NOW ON A DIFFERENT INSTRUMENT. THE CUSTOMER CALLED BACK ON (B)(6) 2014 AND REQUESTED ASSISTANCE WITH ESTIMATING THE AMOUNT OF BLOOD NOT RETURNED TO THE PATIENT WHEN THE TREATMENT WAS ABORTED. THE CLINICAL SERVICES SPECIALIST ASSISTED THE CUSTOMER IN USING TECHNICAL BULLETIN CLX #08 TO ESTIMATE THE VOLUME PRESENT IN THE PROCEDURAL KIT COMPONENTS. THE CUSTOMER WAS SATISFIED WITH THE ASSISTANCE PROVIDED. THE PATIENT WAS REPORTED IN STABLE CONDITION. THE SYSTEM PRESSURE DOME WAS RETURNED FOR EVALUATION ON 09/19/2014. SERVICE ORDER, (B)(4), WAS GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617222 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C122-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR