BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 4279544 · Received November 21, 2014

    Report

    Report Number
    2523595-2014-00300
    Event Type
    Death
    Date Received
    November 21, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED, THEREFORE, NO BATCH RECORD REVIEW WAS PERFORMED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, LOW PLATELETS, GENERAL PHYSICAL HEALTH DETERIORATION, AND DEATH AND NO TRENDS WERE DETECTED. THIS ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THIS REPORT. NO PRODUCT WAS RETURNED FOR EVAL, THEREFORE, IT COULD NOT BE DETERMINED IF THIS SPECIFIC PRODUCT MET SPECIFICATIONS. BASED ON INTERNAL MEDICAL ASSESSMENT, PT SUFFERED FROM EPISODES OF BLOODY DIARRHEA DUE TO GVHD AND LATER ECP TREATMENT WAS STOPPED. PT EVENTUALLY DIED OF WORSENING GVHD. THERE IS NO RELATIONSHIP TO ECP. THIS CASE IS REPORTABLE BECAUSE IT IS SERIOUS YET UNRELATED. ACCORDING TO THE PHYSICIAN, THE PT'S DEATH WAS MOST LIKELY A CONSEQUENCE OF UNCONTROLLED GVHD. THERE IS NO RELATIONSHIP TO ECP. THERAKOS WAS NOTIFIED OF THE PT OUTCOME ON (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    NURSE CALLED ON (B)(6) 2014 AND ASKED IF ECP COULD BE SAFELY PERFORMED. PT WITH LOW HEMATOCRIT WAS ADMITTED TO THE HOSP ONE DAY PRIOR TO RECEIVING ECP, FOR A BLOOD COUNT. PT HAD HCT OF 24% FOR WHICH HE RECEIVED PRBC'S. THIS IS STANDARD PROCEDURE REGARDING THE REQUIREMENTS FOR MINIMAL HCT% FOR ECP. THE CURRENT HCT% WAS REQUESTED BUT NOT PROVIDED. CUSTOMER NOW NOTICED THAT THE PLATELET COUNT DECREASED FROM 16,000 TO 8,000. AFTER REPEATED ATTEMPTS TO F/U, THE PHYSICIAN CONVEYED THE FOLLOWING INFO ON (B)(6) 2014: WE REPORT A (B)(6) MALE PT, ADMITTED TO OUR WARD AT (B)(6), WITH A GRAFT-VERSUS-HOST INVOLVING LIVER (GRADE III) AND INTESTINE (GRADE III). THE PT UNDERWENT AN ALLOGENIC STEMCELL TRANSPLANTATION IN OUR TRANSPLANTATION UNIT ON (B)(6) 2014 BECAUSE OF A MYELODYSPLASTIC MYELOPROLIFERATIVE OVERLAP SYNDROME FIRST DIAGNOSED (B)(6) 2014. FOR THE CONDITIONING THERAPY A COMBINATION OF CYCLOPHOSPHAMID (2 X 60 MG/QM) ANTITHYMOCYTE GLOBULIN (3 X 10 MG/KG BODY-WEIGHT), TOTAL BODY-IRRADIATION (12 GY CUMULATIVE). FOR THE GVHD PROPHYLAXIS CICLOSPORIN A (BLOOD LEVEL ADJUSTED) A MYCOPHENOLATE MOFETIL WERE USED. SHORTLY AFTER THE TRANSPLANTATION THE PT DEVELOPED DIARRHEA. THE RECTOSCOPY SHOWED AN INFLAMMATION WHICH WAS PROOFED BY THE PATHOLOGY DEPARTMENT AS GRADE III TO IV INTESTINAL GVHD. THE INITIAL TREATMENT WITH STEROIDS (PREDNISOLONE 100 MG/D IV, BUDESONIDE 3 X 6 MG/D) SHOWED NO EFFECT AND AS A MATTER OF FACT WE STARTED A THERAPY WITH ALEMTUZUMAB AND ADMINISTERED 5 MG ON A WEEKLY BASIS UNTIL WE REACHED A CUMULATIVE DOSE OF 30 MG. IN THE MEANTIME, THE DIARRHEA WORSENED TO GRADE IV FOR SEVERAL DAYS (FREQUENCY TILL 8/DAY, BLOODY DISCHARGE). WE DECIDED ON A THERAPY CHANGE AND ASKED OUT COLLEAGUES FROM THE DERMATOLOGIC DEPT TO START AN EXTRACORPORAL PHOTOPHORESIS. SLOWLY THE CLINICAL FEATURES SHOWED IMPROVEMENT. THE FREQUENCY OF THE DIARRHEA DECREASED TO 4 TIMES A DAY AND THERE WAS NO MORE BLOOD VISIBLE. AFTER 5 MONTHS THE PT WAS DISCHARGED ON (B)(6) 2014. THE BLOOD TESTS SHOWED AN INCREASE OF LIVER-ENZYMES. ONCE AGAIN WE DECIDED ON A TREATMENT WITH HIGHDOSE STEROIDS (PREDNISOLONE 250 MG FOR 6D AND WAS REDUCED AFTERWARDS TO 100 MG/D, BUDESONIDE 3 X 6 MG/D). ALEMTUZUMAB 5 MG WAS ALSO ADMINISTERED ONCE. THE PHOTO-THERAPY WAS ALSO CONTINUED. DESPITE ALL CHOSEN EFFORTS THE CLINICAL CONDITION DID NOT TURN TO THE BETTER. THE BLOOD TESTS SHOWED A GVHD OF THE LIVER THAT TURNED SLOWLY TO GRADE IV AND THE DIARRHEA HAD BLOOD DISCHARGE ONCE MORE. THE ECP THERAPY HAD TO BE INTERRUPTED, THE PT AND HIS FAMILY REFUSED TO CARRY ON WITH THE ADMINISTRATION OF ALEMTUZUMAB. AFTERWARDS WE SAW A FURTHER DECAY OF THE PT'S PERFORMANCE. THE PT DIED ON (B)(6) 2014. RETROSPECTIVELY THE PT'S DEATH WAS MOST LIKELY A CONSEQUENCE OF THE UNCONTROLLED GVHD. NO THERAPEUTIC MEANS WE CHOSE COULD ALTER THE COURSE OF DISEASE. A DIRECT LINK BETWEEN THE FATAL OUTCOME AND THE USE OF THE EXP SEEMS TO BE MOST UNLIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757947 THERAKOS XTS PHOTOPHERESIS SYSTEM XTS LNR THERAKOS, INC. RNP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death