BEUDAMED
    FDA Adverse Event Other Summary report: N

    UVAR XTS

    MDR report key: 1064817 · Received June 23, 2008

    Report

    Report Number
    2523595-2008-00002
    Event Type
    Other
    Date Received
    June 23, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE FAILURE. PATIENT TOLERATED THE SECOND THERAPY USING ALTERNATE ANTICOAGULANT. CURRENTLY HEPARIN IS THE ONLY ANTICOAGULANT RECOMMENDED IN OUR LABELING BUT THERAKOS IS COMMUNICATING WITH FDA AND IS IN THE PROCESS OF PREPARING LABELING UPDATES USING ACD.

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL BECAUSE OF DECREASED ORAL INTAKE FOR THE PLACEMENT OF A PERCUTANEOUS ENTERAL FEEDING TUBE. DURING THE PATIENT'S INPATIENT HOSPITALIZATION AND ONE WEEK AFTER THE ENTERAL FEEDING TUBE PLACEMENT, THE PATIENT UNDERWENT HIS FIRST ECP PROCEDURE FOR THE TREATMENT OF CGVHD. FOR THE PROCEDURE, THE ECP OPERATOR USED HOSPIRA HEPARIN, LOT #63560LL, AND EMPLOYED TWO 5,000 UNIT VIALS TO PREPARE A 1-LITER SOLUTION (10:1). THE AVERAGE DRAW RATE WAS 23-26 ML/MINUTE. AFTER THE ECP PROCEDURE WAS COMPLETED, THE PATIENT WAS RETURNED TO THE FLOOR FOR OBSERVATION. THE PATIENT THEN DEVELOPED EPISTAXIS WHICH LASTED FROM 1330 HRS TO 1800 HRS AND WHICH WAS TREATED WITH THROMBIN SPRAY, NASAL PRESSURE, AND ICE. THERE WAS NO PRIOR HISTORY OF EPISTAXIS FOR THE PATIENT. NO BLEEDING FROM OTHER SITES (E.G., GUMS OR URINARY TRACT) WAS NOTED. THE DAY AFTER THE EPISTAXIS, THE PATIENT WAS SCHEDULED FOR A SECOND ECP TREATMENT. HOWEVER, THE PRE-ECP HEMATOCRIT WAS 24% IN 2008, AND THE PATIENT RECEIVED TWO UNITS OF PACKED ERYTHROCYTES PRIOR TO THE SECOND ECP TREATMENT, WHICH WAS CONDUCTED WITH ACID-CITRATE-DEXTROSE AS ANTICOAGULATION. THE PATIENT'S HOSPITALIZATION WAS NOT PROLONGED BECAUSE OF EPISTAXIS FOR THE TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UVAR XTS PHOTOPHERESIS KIT LNR THERAKOS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other