BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 2093680 · Received April 20, 2011

    Report

    Report Number
    2523595-2011-00013
    Event Type
    Other
    Date Received
    April 20, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 20, 2011
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTS OF A DEVICE MALFUNCTION HAVE BEEN RECEIVED TO DATE AS IT RELATES TO THIS EVENT. THE EVENT PNEUMONIA WAS ASSESSED BY THERAKOS AS RELATED. THE EVENT OF SEIZURES WAS ASSESSED BY THERAKOS AS UNRELATED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT WITH A HISTORY OF MYELODYSPLASTIC SYNDROME, STATUS POST BONE MARROW TRANSPLANT ((B)(6) 2010) PRESENTED TO THE EMERGENCY ROOM AS A TRANSFER PATIENT WITH RESPIRATORY DISTRESS AND BILATERAL PNEUMONIA. PATIENT WAS ADMITTED TO CCMU WHERE HE WAS NOTED TO HAVE MARKED MUSCLE JERKING AND AGITATION WHICH LESSENED SOMEWHAT WHEN THE PATIENT SLEPT/RELAXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM XTS ECP TREATMENT LNR THERAKOS XTS Y762

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O