BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, PHOTOPHERESIS PROCEDURAL

    MDR report key: 2291889 · Received October 2, 2011

    Report

    Report Number
    2291889
    Event Type
    Malfunction
    Date Received
    October 2, 2011
    Date of Event
    September 19, 2011
    Report Date
    September 30, 2011
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PRIMING OF THE CELLEX INSTRUMENT PRIOR TO INITIATING PATIENT TREATMENT, SEVERAL PRIME TEN ALARMS OCCURRED. THEY WERE UNRESOLVABLE AFTER ATTEMPTING TO TROUBLE SHOOT. THEN SYSTEM ALERT FAILURE OCCURRED. THERAKOS WAS NOTIFIED AND A DISPOSABLE KIT WITH HEPARIN AND SALINE BAGS WAS SEQUESTERED. IT WAS RETRIEVED PER BIOMEDICAL ENGINEERING TO BE RETURNED TO THERAKOS FOR FURTHER INVESTIGATION. THE CELLEX INSTRUMENT TO BE SERVICED PER THERAKOS TECHNICAL SUPPORT. A DIFFERENT INSTRUMENT (XTS) WAS PRIMED WITH A NEW DISPOSABLE KIT. THE TREATMENT WAS INITIATED AND COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PHOTOPHERESIS PROCEDURAL ECP (PHOTOPHERESIS) LNR THERAKOS, INC. * Z306/394

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR OTHER