BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 2982375 · Received February 25, 2013

    Report

    Report Number
    2523595-2013-00010
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 25, 2013
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FIELD ENGINEER RESPONDED TO THE SITE. THE OPTIC SENSOR WAS REPLACED, REPAIRS HAVE RETURNED SERIAL (B)(4) TO EXPECTED OPERATION. THERAKOS MEDICAL STATED FROM THE EXISTING INFO, BASED ON THE INFO PROVIDED, IT IS DIFFICULT TO DISCERN COMPLICATIONS OF AGVHD INCLUDING HEMOLYTIC ANEMIA WITH ALL ITS CONSEQUENCES FROM TMA FROM THE DRUG COMBINATION FROM AN ISOLATED EPISODE OF ECP INDUCED HEMOLYTIC ANEMIA. THE CHRONICITY AND PERSISTENCE OF THE ABNORMAL LABS CLEARLY INDICATE A MUCH MORE CHRONIC STATE RATHER THAN AN ISOLATED EPISODE AS A RESULT OF CONSEQUENCES FROM ECP. THIS EVENT HAS BEEN ASSESSED TO BE SERIOUS, NOT EXPECTED AND RELATED TO THE TREATMENT. THE EVENT IS SERIOUS BASED ON THE ASSESSMENT OF THE REPORTER. THE PT'S CONDITION WAS DEFINED AS BEING STABLE AT THE TIME WHEN THE EVENT WAS REPORTED. THE EVENT IS RELATED TO THE TREATMENT BECAUSE PT RECEIVED UVADEX BEFORE THE EVENT OCCURRED AND IT COULD NOT BE COMPLETELY EXCLUDED. THE OPERATOR REPORTED THAT THE CENTRIFUGE ARM WAS HOT AND THE HG-RIA MAY BE DUE TO ECP AS A RESULT OF OVERHEATING. THE EVENT IS NOT EXPECTED BECAUSE THE HAEMATURIA IS NOT LISTED IN THE PRODUCT CCDS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT SUFFERED FROM HAEMATURIA POST-TREATMENT. NAME AND FUNCTION OF COMPLAINANT/COMPLAINT REPORTER: (B)(6), NURSE. THE EVENT OCCURRED ON (B)(6) 2013. THE EVENT OCCURRED APPROX 30 MINS AFTER THE TREATMENT WAS COMPLETED. REPORTED ON (B)(6) 2013. CUSTOMER REPORTED THAT THE PT VOIDED GROSSLY BLOODY URINE (HEMATURIA) APPROX 30 MINS AFTER THE TREATMENT WAS COMPLETED. A URINALYSIS WAS PERFORMED AND THE LAB REPORTED A "LARGE" AMOUNT OF RED BLOOD CELLS (NO QUANTIFICATION WAS AVAILABLE). CUSTOMER STATED THAT THE LAB REPORTED LYSED RED BLOOD CELLS IN THE MICROSCOPIC EXAMINATION. CUSTOMER STATED THAT THE TREATMENT WAS STARTED AT APPROX 10:20 AM ON (B)(6) 2013 AND COMPLETED AT APPROX 4:15PM ON (B)(6) 2013 WITH A PHOTOACTIVATION TIME OF 20 MINS/56 SECS. THE COMPLAINED CONSIDERS THE EVENT SERIOUS AND THEY ARE INVESTIGATING THE RELATEDNESS TO UVADEX. CUSTOMER STATED THAT THE PT WAS STABLE AT THIS TIME. CUSTOMER NOTICED THAT THE CENTRIFUGE ARM WAS HOT TO THE TOUCH WHILE THE CENTRIFUGE DOOR WAS OPEN DURING PHOTOACTIVATION. CUSTOMER STATED THEY DID NOT NOTICE ANY HEMOLYSIS IN THE BOWL, PHOTOACTIVATION PLATE, BAG OR OTHER PARTS OF THE KIT AT THE TIME OF TREATMENT. OTHER RELEVANT INFO: CELLEX KIT LOT: (B)(4), UVADEX LOT: A89417, EXP. 03/2015. THE INSTRUMENT WAS SET IN SINGLE NEEDLE MODE. A VORTEX PORT WAS USED. TOTAL TREATMENT TIME 6 HOUR 05 MIN (APPROX) 11TH TREATMENT FOR THIS PT. CUSTOMER STATED NO ALARMS HAD OCCURRED DURING THIS TREATMENT BUT THE INTERFACE WAS VERY HIGH IN THE BOWL, ABOUT ONE HALF CENTIMETER FROM THE TIP OF THE BOWL, BUT THE BOWL OPTIC READING WAS ABOUT 150 TO 160. CUSTOMER STATED THIS READING DID NOT CORRELATE WITH THE INTERFACE LEVEL SHE OBSERVED IN THE BOWL. PAUSING THE TREATMENT DID NOT SEEM TO BE HELPING TO BRING THE INTERFACE DOWN MUCH. UPON FTS ADVISE CUSTOMER GET INTO BUFFY COAT COLLECTION AND PROCEED WITH PHOTOACTIVATION (WBP 1380 ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79538 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS 6661 A321

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other