BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAKOS CELLEX

    MDR report key: 1580905 · Received January 14, 2010

    Report

    Report Number
    MW5014348
    Event Type
    Death
    Date Received
    January 14, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 6, 2009
    Manufacturer
    THERAKOS MACK MEDIAL
    Product Code
    LNR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PHOTOPHERESIS IN 2009, AT HOME WAS "DIZZY" AND DID NOT FEEL WELL. PT CALLED AND WAS TOLD TO COME TO THE HOSPITAL THE FOLLOWING DAY. HE WAS IN SEPTIC SHOCK WHEN HE APPEARED IN THE DAY HOSPITAL THE FOLLOWING DAY. TRANSFERRED TO THE ICU WHERE HE EXPIRED. HE HAD A CENTRAL LINE, WHICH WAS CULTURED, THE CULTURES ARE CURRENTLY NEGATIVE. HE EXPIRED THE SAME DAY AFTER TWO FULL CODES, AND WAS ON A VENTILATOR AT THE TIME OF HIS DEATH IN THE ICU. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: CHRONIC GRAFT VERSUS HOST DISEASE. MEDCOMP APHERESIS CATHETER USED FOR THIS PROCEDURE HAD BEEN USED SINCE IMPLANT DATE: NINETEEN DAYS PRIOR TO EVENT. ON NUMEROUS MEDICATIONS FOLLOWING TRANSPLANT, INCLUDING ANTIVIRALS, ANTIFUNGALS, AND BACTRIM ON WEEKENDS; CYCLOSPORINE, PREDNISONE. MEDICATIONS USED DURING PHOTOPHERESIS: HEPARIN, ACD-A, NORMAL SALINE, TPA FOR CLEARING LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS CELLEX PHOTOPHERESIS MACHINE LNR THERAKOS MACK MEDIAL
    2 PHOTOPHERESIS KIT PHOTOPHERESIS KIT LNR THERAKOS MACK MEDIAL X108
    3 MEDCOMP APHERESIS CATHETER NONE MSD MEDCOMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death BACTRIM ON WEEKENDS| TPA FOR CLEARING LINE| MEDICATIONS USED DURING PHOTOPHERESIS: HEPARIN| UVADEX, (METHOXSALEN), LOT: 1770522, EXP: 06/2011,| STRENGTH: 20 MCG/ML, MFR: THERAKOS.| ANTIVIRALS| ANTIFUNGALS| CYCLOSPORINE| ACD-A| PREDNISONE| NORMAL SALINE