BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS PHOTOPHERESIS SYSTEM

    MDR report key: 4475962 · Received January 28, 2015

    Report

    Report Number
    MW5040526
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 12, 2015
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SYSTEM PRESSURE ALARM NOTED; LINES CHECKED FOR KINKS, NO KINKS NOTED IN TUBING SET; PROCEDURE RESTARTED; AFTER RESTART, SYSTEM PRESSURE ALARM OCCURRED X 2. THERAKOS TRAINER AT BEDSIDE; THERAKOS REP REMOVE CENTRIFUGE BOWL TO CONFIRM NO BARRIERS TO BLOOD PATHWAY AND CHECKED FOR AIR. PROCEDURE ABORTED DUE TO PATIENT FLUID BALANCE PARAMETERS. TOTAL WHOLE BLOOD PROCESS WAS 233; TARGET OF 1500 NOT REACHED. TRANSFUSION MEDICINE PHYSICIAN NOTIFIED AND ORDERED TO PROCEED WITH MANUAL RETURN. MANUAL RETURN OF RED CELL PERFORMED VIA BLOOD INFUSION SET. NO PATIENT COMPLICATIONS FOLLOWING PROCEDURE. DISCHARGED HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66024 THERAKOS PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS CELEX C344

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR