BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3553152 · Received January 2, 2014

    Report

    Report Number
    2523595-2014-00018
    Event Type
    Death
    Date Received
    January 2, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    THERAKOS INC
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT FILE B334 WAS PERFORMED. THERE WERE NO NONCONFORMANCES OR ALARMS ASSOCIATED WITH THIS EVENT TYPE REPORTED FOR THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS A REVIEW OF COMPLAINTS RECEIVED FOR LOT B334 WAS PERFORMED. THERE NO OTHER REPORTS OF DEATH TO DATE FOR THIS LOT. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. THE REPORTER STATED THAT SHE DOES NOT BELIEVE THERE WAS A RELATIONSHIP BETWEEN THE EXP TREATMENT AND THE PT DEATH. THE CAUSE OF THE DEATH WAS REQUESTED AND UNK BY THE REPORTER. DESPITE NUMEROUS FOLLOW UP ATTEMPTS TO GATHER MORE INFORMATION FROM THE CUSTOMER, NO RESPONSE NOR ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE. A FOLLOW UP MEDWATCH REPORT WILL BE FILED IF/WHEN ANY ADDITIONAL INFORMATION IS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PT DEATH. NAME OF COMPLAINANT: SAME AS REPORTER. CUSTOMER CALLED TO REPORT A PT EXPIRATION THAT OCCURRED SOMETIME IN THE EARLY MORNING HOURS OF (B)(6) 2013. THE CUSTOMER STATED THEY DO NOT BELIEVE THE PT DEATH IS RELATED TO THE ECP TREATMENT WHICH WAS PERFORMED ALMOST 32 HOURS PRIOR TO DEATH. CLINICAL SERVICES REQUESTED MORE INFORMATION FROM THE CUSTOMER. THE CUSTOMER STATED THAT THEY WOULD CALL BACK WITH MORE INFORMATION. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELEX ECP SYSTEM LNR THERAKOS INC 6661 B334/375 - KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death THE PT WAS ON CONTINUOUS CVVH,ALONG WITH A VARIETY| OF OTHER THERAPIES SUCH AS RESPIRATORY THERAPY.