BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4202562 · Received September 18, 2014

    Report

    Report Number
    2523595-2014-00243
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT C117 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THIS TYPE OF EVENT FOR THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY , ALARM #7: BLOOD LEAK - (CENTRIFUGE CHAMBER). NO TREND WAS DETECTED FOR COMPLAINT CATEGORY, ALARM # 7: BLOOD LEAK - (CENTRIFUGE CHAMBER). THE KIT WAS DISPOSED OF; THEREFORE, THE KIT WILL NOT BE RETURNED FOR EVAL. A PICTURE WAS RECEIVED SO THE PICTURE WILL BE EVALUATED. THIS ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. NO ANALYSIS OF THE RETURNED PICTURE IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THIS ANALYSIS IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ALARM #7 BLOOD LEAK (CENTRIFUGE CHAMBER) AT 1400ML OF WHOLE BLOOD PROCESSED. SHE VERIFIED THE DRIVE TUBE HAD A SMALL HOLE IN THE PORTION BETWEEN THE UPPER AND THE LOWER BEARING RETAINER CLIPS. THE TREATMENT WAS ABORTED. 60 ML OF PLASMA FROM THE RETURN BAG WAS RETURNED TO THE PT. AFTER THE TREATMENT WAS ABORTED, THE PT RECEIVED A BLOOD TRANSFUSION. THE PT IS REPORTED TO BE IN STABLE CONDITION. PICTURE WILL BE SENT. THE CENTRIFUGE CHAMBER AND DOOR HAVE BEEN CLEANED AND THE INSTRUMENT WAS READY FOR PRIME. NO SVC ORDER WAS GENERATED. A PICTURE WAS RETURNED FOR INVESTIGATION ON 09/03/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580906 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C117-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR