BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAKOS UVAR XTS

    MDR report key: 3529729 · Received November 27, 2013

    Report

    Report Number
    2523595-2013-00188
    Event Type
    Other
    Date Received
    November 27, 2013
    Date of Event
    October 31, 2013
    Report Date
    October 31, 2013
    Manufacturer
    THERAKOS INC
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER NOT PROVIDED; THEREFORE, NEITHER BATCH RECORD REVIEW NOR COMPLAINT LOT REVIEW COULD BE CONDUCTED. THERE WAS A REDUCTION IN PLATELET AND RED CELL COUNT, THOUGH WITHIN THE NORMAL RANGE. THIS MAY BE DUE TO HAEMODILUTION OCCURRING AS A RESULT OF FLUID SHIFTS DURING THE ECP TREATMENT. IT IS NOT POSSIBLE TO ARRIVE AT A DEFINITE CAUSAL RELATIONSHIP WITHOUT FURTHER INFORMATION. GIVEN THE UNEVENTFUL PREVIOUS ECP TREATMENTS AND THE LACK OF INFORMATION ON TIMINGS, ANOTHER CAUSE OR THE UNDERLYING GVHD MAY BE THE CAUSE. THERE IS NO PLAUSIBLE BIOLOGICAL RELATIONSHIP TO THE USE OF UVADEX AND NO ADVERSE DRUG REPORT HAS OCCURRED. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. THE ROOT CAUSE FOR THIS COMPLAINT CANNOT BE DETERMINED BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    DOCTORS FOLLOWING THIS PT ARE INQUIRING INTO THE WORSENING OF SOME BLOOD PARAMETERS AFTER ONE TREATMENT. NAME AND FUNCTION OF COMPLAINT: SAME AS REPORTER. PROBLEM DESCRIPTION. CUSTOMER CALLED TO REPORT PT WAS FOUND WITH A THROMBOCYTES DROP FROM 210000 (BEFORE TREATMENT) TO 140000 AFTER THE TREATMENT. ALSO, WHITE CELLS LEVELS WENT FROM 6000 TO 4300. DOCTORS DECIDED TO TRANSFUSE THE PT WITH ONE UNIT OF BLOOD, NO ADDITIONAL INFO ABOUT THE REASON TO TRANSFUSE. BEFORE TREATMENT HAEMOGLOBIN'S VALUE WAS 8.7, AFTER TREATMENT AND TRANSFUSION THE VALUE WAS STILL 8.7, SO CUSTOMER THINKS THERE WAS A DROP IN HAEMOGLOBIN AS WELL. PT IS DOING WELL, NO SYMPTOMS OF SICKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619582 THERAKOS UVAR XTS XTS LNR THERAKOS INC 6660 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other