BEUDAMED
    FDA Adverse Event Death Summary report: N

    XTS PHOTOPHERESIS SYSTEM

    MDR report key: 6749175 · Received July 27, 2017

    Report

    Report Number
    2523595-2017-00159
    Event Type
    Death
    Date Received
    July 27, 2017
    Report Date
    July 27, 2017
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. FROM A DEVICE PERSPECTIVE, THERE WAS NO KNOWN DEVICE MALFUNCTION AND NO INSTRUMENT ISSUE WAS ALLEGED BY THE PRESENTER. HOWEVER, 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 INSTRUMENT'S SERIAL NUMBER WAS NOT PROVIDED IN THE PRESENTATION; THEREFORE, THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES: DEATH AND PULMONARY EMBOLISM. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. 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 AND PULMONARY EMBOLISM. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION FOR THIS CASE CAME FROM A GERMAN PRESENTATION ON THE USE OF ECP IN PATIENTS DIAGNOSED WITH CHRONIC LUNG ALLOGRAFT DYSFUNCTION (CLAD) FOLLOWING LUNG TRANSPLANTATION. THE PRESENTATION MENTIONED THAT 25 OUT OF 252 PATIENTS STOPPED ECP TREATMENT. TWO OF THE 25 PATIENTS STOPPED ECP TREATMENT DUE TO "RELATED" DEATHS FROM AIR EMBOLISMS. IT IS UNCLEAR IF THE "RELATED" DEATHS WERE DUE TO THE PATIENTS' UNDERLYING CONDITION OR DUE TO THEIR ECP TREATMENT. IN A FOLLOW-UP COMMUNICATION WITH THE PRESENTER COULD ONLY CONFIRM THAT ONE OF THE DECEASED PATIENTS HAD BEEN RECEIVING TREATMENT WITH A THERAKOS DEVICE. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526492 XTS PHOTOPHERESIS SYSTEM XTS PHOTOPHERESIS SYSTEM LNR THERAKOS, INC NOT APPLICABLE NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death