BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4202646 · Received September 18, 2014

    Report

    Report Number
    2523595-2014-00244
    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
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C334 WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE NATURE OF THIS COMPLAINT TYPE. THE LOT MET RELEASE REQUIREMENTS. A REVIEW OF LOT C334 SHOWS NO TRENDS. AT THE TIME OF THE INVESTIGATION, NO TREND WAS DETECTED FOR PRESSURE DOME MEMBRANE LEAK. CAPA (B)(4) AND (B)(4) WERE INITIATED FOR COMPLAINT CATEGORY PRESSURE DOME MEMBRANE LEAK. THE PRODUCT WAS NOT RETURNED FOR FURTHER ANALYSIS; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT SYSTEM PRESSURE DOME LEAK DURING TREATMENT. CUSTOMER WAS ASKED IF THERE WERE ANY ALARMS DURING PRIME, CUSTOMER STATED NO THERE WERE NO ALARMS DURING PRIME. CUSTOMER WAS ASKED IF THERE WERE ANY ALARMS PRIOR TO PRESSURE DOME LEAK. CUSTOMER STATED THERE WERE NO ALARMS PRIOR TO LEAK. CUSTOMER IMMEDIATELY ABORTED THE PROCEDURE WITH NO RETURN OF BLOOD PRODUCT TO THE PATIENT. PATIENT WAS IN STABLE CONDITION. KIT HAS BEEN DISCARDED. NO SERVICE ORDER WAS GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580072 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C334-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR