BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAKOS CELLEX

    MDR report key: 3432831 · Received October 16, 2013

    Report

    Report Number
    2523595-2013-00130
    Event Type
    Other
    Date Received
    October 16, 2013
    Date of Event
    July 17, 2013
    Report Date
    September 18, 2013
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT A329 WAS CONDUCTED. A REVIEW OF LOT A329 WAS PERFORMED AND THERE WAS ONE NON-CONFORMANCE, NOT RELATED TO THIS CASE, (B)(4), FOR EXTENDED BI INCUBATION. LOT MET RELEASE REQUIREMENTS. AN INVESTIGATION WAS INITIATED TO REVIEW THE STERILIZATION PROCESSING RECORDS FOR LOT A329. AS PART OF THE INVESTIGATION, A RETAIN SAMPLE FROM LOT A329 WAS SUBMITTED TO A CONTRACT LAB FOR ETHYLENE OXIDE RESIDUAL (EOR) TESTING ON 09/21/2013 FOR BASELINE INFO. THE EOR LEVEL OBTAINED FOR LOT A329 KIT (1.2 MG/DEVICE) IS WITHIN THE SPEC LIMIT FOR CELLEX DEVICES WHICH IS NMT 15 MG/DEVICE. THERE WERE NO ISSUES DURING PROCESSING OF LOT A329 THAT WOULD HAVE AN IMPACT ON THE EOR LEVEL OF THE KITS. THIS IS CONSIDERED AN ISOLATED INCIDENT AS REVIEW OF PAST CUSTOMER EVENTS FOR THE LAST THREE YEARS SOWED NO OTHER OCCURRENCE. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT RETURN WAS RECEIVED BY THE CUSTOMER FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A PT SUFFERING ANAPHYLACTIC SHOCK DURING A CELLEX TREATMENT PROCEDURE. NAME AND FUNCTION OF COMPLAINANT: SAME AS REPORTER. CUSTOMER REPORTED INCIDENT HAPPENED ON (B)(6) 2013. AT 10 MINUTES OF TREATMENT REMAINING, AFTER INJECTION OF UVADEX TO TREATMENT BAG, PT REPORTED ITCHING IN THROAT. ALLERGIC REACTION (ANAPHYLACTIC SHOCK) DEVELOPED, PT WAS FOUND TO BE HAEMOLYTICALLY INSTABLE, WAS HOSPITALIZED IN INTENSIVE CARE UNIT UNTIL THE NEXT DAY. PT WAS ADMINISTERED PREDNISOLONE, HARIGIN AND CORTISONE. AS REACTION OCCURRED AFTER UVADEX INJECTION, INITIALLY THE PHYSICIANS THOUGHT THAT UVADEX CAUSED THE ALLERGY. AFTER EVAL OF THE BLOOD SAMPLE TAKEN ON (B)(6) 2013, UVADEX WAS EXCLUDED AS POSSIBLE CAUSE. BLOOD SAMPLES REVEALED ETHYLENE OXIDE (EO) LEVELS CONSIDERED BY ALLERGIST SUFFICIENT TO CAUSE ALLERGIC REACTION. EO IS USED IN THE STERILIZATION PROCESS OF THERAKOS KITS. CUSTOMER WILL NOT RETURN PRODUCT FOR INVESTIGATION. VOLUME OF UVADEX WAS REQUESTED BUT UNK. PHOTOACTIVATION TIME REQUESTED AND UNK. PT IS WELL TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531056 THERAKOS CELLEX CELLEX LNR THERAKOS, INC. 6661 A329 KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR