BEUDAMED
    FDA Adverse Event Other Summary report: N

    UVAR XTS

    MDR report key: 1215629 · Received October 23, 2008

    Report

    Report Number
    2523595-2008-00003
    Event Type
    Other
    Date Received
    October 23, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE FAILURE. OUR LABELING DOES NOT ALLOW FOR THE USE OF CITRATE AS THE ANTICOAGULANT APPROVED FOR PHOTOPHERESIS.

    Description of Event or Problem · 1

    THE PATIENT IS A (B) (6) (B) (6) FEMALE WITH A HISTORY OF GRAFT-VERSUS-HOSE DISEASE THAT WAS TREATED IN THE PAST WITH EXTRACORPOREAL PHOTOPHERESIS (ECP). DUE TO THE PATIENT'S DISEASE, ECP WAS PRESCRIBED AGAIN AND THE PATIENT HAD A CENTRAL CATHETER PLACED ON (B) (6) 2008. SLIGHT OOZING OF BLOOD HAD BEEN NOTED FROM THE CENTRAL CATHETER PLACEMENT SITE. AT THAT TIME, THE PLATELET COUNT WAS 60,000/CMM. IN THE AFTERNOON OF (B) (6) 2008, THE PATIENT HAD HER FIRST ECP TREATMENT WITH 300CC OF 10,000U HEPARIN WITHOUT DIFFICULTY. ON THE FOLLOWING DAY, (B) (6) 2008, THE PATIENT RECEIVED A SECOND ECP TREATMENT WITH 300CC OF 10,000U HEPARIN. AT THE END OF THE PROCEDURE, OOZING OF BLOOD AND EXPANDING HEMATOMA WERE NOTED AT THE CENTRAL LINE INSERTION AREA. IMMEDIATELY AFTER COMPLETION OF THE PROCEDURE, SHE WAS NOTED TO HAVE PAINLESS GROSS HEMATURIA. POST-ECP LABORATORY VALUES (DRAWN FROM A PERIPHERAL SITE, AND APPROXIMATELY 90 MINUTES AFTER THE PROCEDURE WAS COMPLETED) DEMONSTRATED A PLATELET COUNT OF 60,000/CMM, A NORMAL PROTHROMBIN TIME AND A PARTIAL THROMBOPLASTIN TIME OF GREATER THAN 200 SECONDS. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL FOR OBSERVATION. PROTAMINE WAS ADMINISTERED AND THE PATIENT WAS TRANSFUSED WITH TWO UNITS PACKED ERYTHROCYTES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B) (6) 2008. ADDITIONAL INFORMATION REGARDING THE HOSPITALIZATION WERE OTHERWISE UNKNOWN. THE TREATMENT CENTER DOES NOT CONSIDER THIS BLEEDING INCIDENT AS RELATED TO ECP OR THE PROCEDURE BUT RATHER AS POSSIBLY RELATED TO THE USE OF HEPARIN. THE PATIENT IS SCHEDULED TO UNDERGO FUTURE ECP TREATMENTS WITH LOWER DOSES OF HEPARIN OR THE USE OF CITRATE AS AN ANTICOAGULANT. POST-ECP, HEMATOCRIT VALUES WERE NOT AVAILABLE AND THE SITE WAS NOT AWARE OF THE EVENTS THAT TRANSPIRED IN THE HOSP AND DIDN'T HAVE ANY RECORDS FROM THE HOSP, SPECIFICALLY IF AN IVP OR CYSTOSCOPY WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O