BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 6509157 · Received April 20, 2017

    Report

    Report Number
    2523595-2017-00082
    Event Type
    Death
    Date Received
    April 20, 2017
    Report Date
    April 20, 2017
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THE INSTRUMENT'S SERIAL NUMBER WAS NOT PROVIDED IN THE ARTICLE; THEREFORE, THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, DEATH AND LACK OF EFFICACY. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. FROM A DEVICE PERSPECTIVE: SINCE THE DEVICE COULD NOT BE RULED OUT AS A POSSIBLE CONTRIBUTING FACTOR TO THIS EVENT, THIS CASE WILL BE REPORTED AS A MDR OUT OF AN ABUNDANCE OF CAUTION. SINCE THIS EVENT IS ASSOCIATED WITH THE TREATMENT, THIS MDR WILL BE AGAINST THE INSTRUMENT. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. ADVERSE EVENT TERMS: DEATH. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IN A POSTER ABSTRACT WRITTEN BY NELSON ET AL. (BIOL BLOOD MARROW TRANSPLANT 22 (2016) S19-S481), A STUDY WAS PERFORMED ON PATIENTS BEING TREATED FOR GRAFT VERSUS HOST DISEASE (GVHD) USING EXTRACORPOREAL PHOTOPHERESIS (ECP). THE ABSTRACT REPORTED THAT "FOUR PATIENTS WERE NOT EVALUABLE DUE TO DEATH BEFORE 3 MONTH." NO SPECIFIC DATE OR CAUSE OF DEATH WAS PROVIDED FOR ANY OF THESE PATIENTS IN THE ABSTRACT. THE LENGTH OF THEIR EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT WAS ALSO UNKNOWN. THE ABSTRACT ALSO STATED THAT ONE PATIENT HAD NO RESPONSE TO ECP. THERE WAS NO FURTHER INFORMATION REGARDING THIS PATIENT IN THE ABSTRACT. THE INSTRUMENT WAS NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288218 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS, INC NOT APPLICABLE NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death