BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 2011781 · Received February 22, 2011

    Report

    Report Number
    2523595-2011-00007
    Event Type
    Other
    Date Received
    February 22, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 22, 2011
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTS OF A DEVICE MALFUNCTION HAVE BEEN RECEIVED TO DATE AS IT RELATES TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED THAT AFTER CYCLES 1 AND 2 WERE COMPLETED, THE PATIENT EXPERIENCED SOME BREATHING TROUBLE. THE TREATMENT WAS THEN PAUSED FOR ABOUT HALF AN HOUR. CUSTOMER STATED THIS ICU PATIENT HAS GVHD WITH LUNG AND GUT INVOLVEMENT WHICH SHE BELIEVED WAS RELATED TO HIS BREATHING TROUBLE. CUSTOMER STATED THEY DECIDED TO ABORT THE TREATMENT AND NOT RETURN THE CELLS LEFT IN THE KIT AT THE END OF CYCLE 2. CUSTOMER STATES MALE PATIENT, WEIGHT IS 73.1 KG, HCT IS 34.9, AND ESTIMATED 185 ML WHOLE BLOOD WAS NOT RETURNED TO THE PATIENT. CUSTOMER STATES PATIENT REGAINED NORMAL BREATHING AND VITALS WERE STABLE. CUSTOMER STATES AC FLUID USED DURING TREATMENT WAS 213 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM XTS ECP TREATMENT LNR THERAKOS XTS Y752

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UVADEX: PER ECP TREATMENT| METHOXSALEN: PER ECP TREATMENT