BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLXECP KIT

    MDR report key: 1463521 · Received September 3, 2009

    Report

    Report Number
    2523595-2009-00006
    Event Type
    Death
    Date Received
    September 3, 2009
    Date of Event
    August 27, 2009
    Report Date
    August 27, 2009
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CENTER WAS INSTRUCTED TO STOP USING THE INSTRUMENT UNTIL IT COULD BE EVALUATED.

    Description of Event or Problem · 1

    THE PT RECEIVED A BONE MARROW TRANSPLANT IN 2008 FOR THE TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA. AFTER THE TRANSPLANT, THE PT DEVELOPED GRAFT-VERSUS-HOST DISEASE OF THE LUNG WITH PERSISTENT COUGH. THERE WAS NO HISTORY OF FOOD ALLERGIES OR ANY OTHER MEDICAL CONDITIONS. APPROX SIX WEEKS PRIOR TO THE ECP TREATMENT, THE PT UNDERWENT AN ATTEMPTED DIAGNOSIS BRONCHOSCOPY, BUT HAD OXYGEN DESATURATION TO 70% DURING THE PREPARATION FOR THE PROCEDURE, WHICH WAS THEN CANCELLED. THE PT WAS SCHEDULED FOR HIS FIRST ECP TREATMENT IN 2009. THE BASELINE LABORATORY EVAL WAS UNREMARKABLE AND THE PT RECEIVED A FULL ECP TREATMENT UTILIZING HEPARIN AS THE ANTI-COAGULANT AS WELL AS DOUBLE-NEEDLE ACCESS THROUGH A CENTRAL LINE. THE PROCEDURE WAS NOTED TO BE UNEVENTFUL. NO DEVICE ALARMS WERE ACTUATED AND THE PROCEDURE LASTED 1 HOUR AND 39 MINUTES. THE PT COUGHED DURING THE PROCEDURE, BUT THE COUGHING WAS NOTED TO BE NO DIFFERENT THAN THE PT'S PRE-PROCEDURE CONDITION. AT THE COMPLETION OF THE PROCEDURE, THE CENTRAL LINE WAS FLUSHED WITH 5 ML OF HEPARINIZED SALINE 10 IU/ML, AND SHORTLY THEREAFTER STARTED TO HAVE AN EXACERBATION OF COUGH AND DEVELOPMENT OF DYSPNEA. THESE SYMPTOMS WERE TREATED WITH A SALBUTAMOL INHALER AND A DOSE OF EPINEPHRINE. APPROX 2.5 HOURS FOLLOWING THE COMPLETION OF THE ECP PROCEDURE, THE PT WAS INTUBATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER MGMT. IN THE ICU, THE PT WAS TREATED EMPIRICALLY FOR BRONCHOSPASM, MUCOUS PLUG, AND INFECTION. A CHEST RADIOGRAPH DID NOT DEMONSTRATE A PNEUMOTHORAX. THE PT HAD A CARDIAC ARREST AT 22:00 HOURS FROM WHICH HE WAS SUCCESSFULLY RESUSCITATED, BUT HAD A SUBSEQUENT CARDIAC ARREST AT 0200 HOURS THE NEXT DAY, AND EXPIRED. AN AUTOPSY WAS SCHEDULED AND THERAKOS HAS REQUESTED THE RESULTS WHEN AVAILABLE. THE ATTENDING PHYSICIAN HAS DEEMED THAT THE RESPIRATORY AND CARDIAC EVENTS WERE NOT RELATED TO THE ECP PROCEDURE OR TO UVADEX. THIS IS BEING REPORTED DUE TO THE CLOSE PROXIMITY OF THE PT'S DEATH TO THE TREATMENT. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLXECP KIT CELLEX PHOTOPHERESIS KIT LNR THERAKOS, INC. CLXECP

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death BONE MARROW TRANSPLANT