BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 6502633 · Received April 18, 2017

    Report

    Report Number
    2523595-2017-00078
    Event Type
    Death
    Date Received
    April 18, 2017
    Report Date
    April 18, 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 CATEGORY, DEATH. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. 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

    DURING A LITERATURE REVIEW OF AN ARTICLE WRITTEN BY KAPADI ET AL., PEDIATR BLOOD CANCER 2015;62:1485-1488, IT WAS NOTED THAT A PATIENT DEATH WAS REPORTED. THE ARTICLE STATED THAT AN INSTITUTIONAL REVIEW BOARD STUDY WAS PERFORMED. THIS STUDY TOOK PLACE FROM SEPTEMBER 2010 TO MAY 2014. THE ARTICLE MENTIONED THAT PATIENT #9 (REFERENCED AS SUCH IN THE ARTICLE) PASSED AWAY DUE TO SEPTIC SHOCK. NO SPECIFIC DATE OF DEATH WAS PROVIDED FOR THIS PATIENT IN THE ARTICLE. THE PATIENT WAS BEING TREATED FOR ACUTE GRAFT VERSUS HOST DISEASE (GVHD). THIS PATIENT HAD A SITE/STAGE OVERALL GVHD GRADE OF IV (GUT-4 AND LIVER-4). ACCORDING TO THE ARTICLE, THIS PATIENT WAS TREATED WITH EXTRACORPOREAL PHOTOPHERESIS (ECP) FOR ONE MONTH AND HAD AN ACTIVE RESPONSE TO THE TREATMENT. PRIOR TO ECP, THE PATIENT WAS TREATED WITH PREDNISONE AND INFLIXIMAB. DURING THE ECP TREATMENTS, THIS PATIENT WAS ONLY TREATED WITH PREDNISONE. NO OTHER INFORMATION REGARDING THIS PATIENT WAS PROVIDED IN THE ARTICLE. THE INSTRUMENT WAS NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283783 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS, INC NOT APPLICABLE NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death