BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELLEX

    MDR report key: 1572256 · Received January 6, 2010

    Report

    Report Number
    2523595-2010-00001
    Event Type
    Death
    Date Received
    January 6, 2010
    Date of Event
    December 23, 2009
    Report Date
    January 6, 2010
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERAKOS FIELD ENGINEER ARRIVED AT THE SITE IN 2009 TO EVALUATE THE DEVICE. THE DEVICE WAS FOUND TO FUNCTION AS INTENDED. THIS IS THE ONLY EVENT OF THIS NATURE TO HAVE OCCURRED; NO TREND HAS BEEN IDENTIFIED. THE DHR AND BATCH RECORD WERE REVIEWED AND CONFIRMED TO HAVE MET SPECIFICATION REQUIREMENTS FOR LOT RELEASE. TKS # 45371 AND 45372.

    Description of Event or Problem · 1

    A PATIENT WHO HAD A HISTORY OF ACUTE MYELOGENOUS LEUKEMIA WITH CENTRAL NERVOUS SYSTEM INVOLVEMENT, HAD BEEN TREATED AND WAS IN REMISSION. FOLLOWING A RELAPSE OF HIS DISEASE, THE SUBJECT UNDERWENT A PERIPHERAL BLOOD STEM CELL TRANSPLANT. THE POST-TRANSPLANTATION COURSE WAS COMPLICATED BY THE DEVELOPMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE FOR WHICH THE PATIENT RECEIVED HIGH DOSES OF CORTICOSTEROIDS. THE PATIENT COULD NOT BE TAPERED FROM HIS CORTICOSTEROIDS, SO A COURSE OF EXTRACORPOREAL PHOTOPHERESIS (ECP) WAS CONSIDERED. A CENTRAL VENOUS LINE WAS PLACED IN 2009, BUT IT BECAME INFECTED WITH VEILLONELLA SP. AND THE LINE WAS REMOVED AFTER THE PATIENT HAD AN ACUTE PRESENTATION SUGGESTIVE OF SEPSIS (AFEBRILE, BUT WITH ELEVATED TOTAL LEUKOCYTE COUNT) AND AN INPATIENT HOSPITALIZATION FOR ANTIBIOTIC TREATMENT AND CATHETER REMOVAL. THE VEILLONELLA SP. BACTERIUM GREW 24 HOURS AFTER THE BLOOD CULTURE WAS TAKEN. THE PATIENT THEN HAD A NEW CENTRAL VENOUS LINE PLACED, AND UNEVENTFUL ECP PROCEDURES WERE PERFORMED USING A CELLEX MACHINE THE FOLLOWING MONTH. THREE WEEKS LATER, THE PATIENT REPORTED FOR A ROUTINELY SCHEDULED ECP PROCEDURE. THE HEMOGLOBIN WAS 10.0 GRAMS% AND THE HEMATOCRIT WAS 27%. THE TOTAL LEUKOCYTE COUNT WAS 5,300/ CMM, AND THE TOTAL PLASMA CALCIUM WAS 8.8 MEQ/L. PRIOR TO THE PROCEDURE, THE CENTRAL VENOUS LINE WAS CLEARED WITH TISSUE PLASMINOGEN ACTIVATOR. THE PRE-ECP BLOOD PRESSURE WAS 132/66 MM HG AND THE PRE-ECP HEART RATE WAS ELEVATED AT 129/MINUTE. THE BLOOD PRESSURE REACHED A NADIR OF 113/62 AND THE HEART RATE DROPPED AS LOW AS 103/MINUTE DURING THE ECP PROCEDURE. ACDA WAS USED AS AN ANTICOAGULANT AND IONIZED CALCIUM LEVELS WERE ACCEPTABLE DURING THE PROCEDURE, RANGING FROM 1.07 TO 1.14 MEQ/L. A TOTAL VOLUME OF 1604 ML WAS NOTED AND A TREATED VOLUME OF 256 ML WAS RECORDED. THE ECP OPERATOR AND TREATING PHYSICIAN DESCRIBED THE ENTIRE ECP PROCEDURE AS UNEVENTFUL, AND THE PATIENT WAS ASYMPTOMATIC UPON DISCHARGE FROM THE TREATMENT UNIT. THE PROCEDURE WAS COMPLETED AT APPROXIMATELY 3:30 PM LOCAL TIME. FOLLOWING ARRIVAL AT HOME, THE PATIENT COMPLAINED OF NAUSEA, EMESIS, DIZZINESS AND DIARRHEA, WHICH WAS TYPICAL FOR THE PATIENT AFTER A COURSE OF ECP. HE TELEPHONED THE PEDIATRIC HEMATOLOGY-ONCOLOGY, FELLOW ON CALL WHO DEEMED THE SYMPTOMS BOTH TYPICAL AND NON-SERIOUS, AND PRESCRIBED ONDANSETRON AND DIPHENHYDRAMINE AND ARRANGED TO HAVE THE PATIENT SEEN IN THE OUTPATIENT CLINIC ON THE NEXT MORNING. THE PATIENT REPORTED TO THE OUTPATIENT CLINIC AT APPROXIMATELY 1000 HRS LOCAL TIME TWO DAYS LATER, FOR FURTHER EVALUATION. THE IMMEDIATE CLINICAL IMPRESSION AT PRESENTATION WAS THAT THE PATIENT WAS IN FLORID BACTERIAL SEPSIS, AND HE WAS DIRECTLY ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS NOTED TO BE SEVERELY HYPOTENSIVE ON ARRIVAL AND WAS UNABLE TO OXYGENATE ON SUPPLEMENTAL OXYGEN. THE PATIENT DEVELOPED REPETITIVE SEIZURES AND PROGRESSED TO A BRIEF CARDIOPULMONARY ARREST FROM WHICH HE WAS RESUSCITATED. FOLLOWING URGENT INTUBATION AND MECHANICAL VENTILATION, THE PATIENT HAD REFRACTORY METABOLIC ACIDOSIS AND HYPOTENSION REQUIRING MULTIPLE PARENTERAL INJECTIONS OF SODIUM BICARBONATE, AND THE ADMINISTRATION OF NOREPINEPHRINE AND EPINEPHRINE. THE PATIENT WAS ABLE TO BE STABILIZED BRIEFLY WITH AN INFUSION OF VASOPRESSIN, BUT BECAME PROFOUNDLY HYPOTENSIVE AFTER STABILIZATION. VIGOROUS FLUID RESUSCITATION OF THE HYPOTENSION LED TO ACUTE PULMONARY EDEMA AND COPIOUS NON-HEMORRHAGIC SECRETIONS WERE ASPIRATED FROM THE SUBJECT'S ENDOTRACHEAL TUBE. A BEDSIDE 2-DIMENSIONAL ECHOCARDIOGRAM DEMONSTRATED GLOBAL HYPOCONTRACTILITY WITH A LEFT VENTRICULAR EJECTION FRACTION OF 26%. BECAUSE OF DIFFICULTY WITH OXYGENATION, EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS CONSIDERED, BUT THE PATIENT SUFFERED A SECOND CARDIOPULMONARY ARREST DURING PREPARATIONS FOR THE ECMO PROCEDURE FROM WHICH THE PATIENT COULD NOT BE RESUSCITATED. THE PATIENT WAS PRONOUNCED DEAD APPROXIMATELY 12 HOURS AFTER ADMISSION TO THE INTENSIVE CARE UNIT. AN AUTOPSY WAS REFUSED BY THE FAMILY. TWO BLOOD CULTURES AND ONE URINE CULTURE COLLECTED UPON ADMISSION TO THE INTENSIVE CARE UNIT THE SAME DAY, HAVE YIELDED NO BACTERIAL GROWTH AS OF ONE WEEK LATER. THE TREATING PHYSICIAN WHO ATTENDED THE ECP PROCEDURE DOES NOT BELIEVE THAT THE POST-ECP COURSE, AND PATIENT'S DEATH WAS RELATED TO EITHER THE CELLEX ECP PROCEDURE OR METHOXSALEN ADMINISTRATION. DIAGNOSIS FOR USE: "GVHD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLEX CELLEX LNR THERAKOS CELLEX X108

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death NASAL CORTICOSTEROIDS| ESCITALOPRAM| NOREPINEPHRINE AND EPINEPHRINE| METHOXSALEN, PER ECP TREATMENT 042| UVADEX, LOT # 1770522, EXP. DATE: 06/01/2011| SULFAMETHOXAZOLE / TRIMETHOPRIM AND FLUCONAZOLE| CORTICOSTEROIDS| ANTIBIOTICS CVL REMOVAL VEILLONELLA SP.| PROPHYLACTIC BACTRIM