BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4275839 · Received November 20, 2014

    Report

    Report Number
    2523595-2014-00299
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 28, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED; THEREFORE, NO BATCH RECORD REVIEW WAS PERFORMED. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, GASTROINTESTINAL HEMORRHAGE, AND NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THIS ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THIS REPORT. NO PRODUCT WAS RETURNED FOR EVAL; THEREFORE, IT COULD NOT BE DETERMINED IF THIS SPECIFIC PRODUCT MET SPECS. THIS CASE IS BEING REPORTED BECAUSE OF THE MEDICAL INTERVENTION GIVEN TO THE PT; THE PT RECEIVED ANTIDOTE TO HEPARIN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CONTACTED CLINICAL SERVICES SPECIALIST REGARDING A PT WHO THEY HAVE JUST STARTED TREATING WITH ECP. THE PT WAS TRANSPLANTED WITH BONE MARROW IN (B)(6) AND STARTED ECP ON (B)(6). THE PT IS BLEEDING FROM THE GUT. SHE HAS HAD TWO TREATMENT CYCLES (2 TREATMENT/CYCLE) FOR TWO CONSECUTIVE WEEKS AFTER THE LAST TREATMENT, SHE WAS GIVEN ANTIDOTE TO HEPARIN. SHE SHOULD HAVE STARTED A NEW TREATMENT CYCLE AGAIN ON (B)(6), BUT SHE HAD BEEN BLEEDING TOO MUCH DURING THE NIGHT SO THE DOCTORS CANCELED THE TREATMENT. THEY ARE HOPING TO TREAT HER TOMORROW. NURSES WANTED TO KNOW IF THERAKOS HAS EXPERIENCE OF SIMILAR ISSUES OR OF ANTIDOTES TO HEPARIN. THERAKOS MEDICAL AFFAIRS PROVIDED A RESPONSE TO THE CUSTOMER. THEY ALSO ASKED IF THERE ANY OTHER OPTIONS TO HEPARIN. CSS SAID THAT WE ONLY HAVE OFFICIAL GUIDELINES FOR HEPARIN AND ADVISED NURSES TO DISCUSS WITH OTHER CENTERS WITH WHOM THEY HAVE ALREADY BEEN IN CONTACT REGARDING PEDIATRIC TREATMENT. NURSES AGREE THAT THE FINAL DECISION IS THE DOCTOR'S, BUT THEY WOULD LIKE TO GET INFO ABOUT DIFFERENT OPTIONS IN ORDER TO PRESENT THOSE TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752582 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. RNP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention