BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3784055 · Received April 25, 2014

    Report

    Report Number
    MW5035844
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    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

    EXTRACORPOREAL PHOTOPHERESIS TREATMENT PROCEDURE WAS ABORTED USING THERAKOS CELLEX DEVICE DUE TO OPTIC BOWL SENSOR READING'S FAILURE TO MAINTAIN AT 150 THRESHOLD LEVEL AS REQUIRED BY MFR. THE CELLEX CIRCUIT WAS REPURGED 2 TIMES (PT ON BLOOD PRIME) WITHOUT SUCCESS. THERAKOS WAS CONTACTED BY PHONE; BOTH MFR AND ECP RN WENT THROUGH FURTHER TROUBLESHOOTING MEASURES WITHOUT SUCCESS. TRANSFUSION MD AT PT'S BEDSIDE AND ORDERED TO ABORT TREATMENT PROCEDURE. REMAINING PRBC BLOOD PRIME WAS RETURNED TO BLOOD BANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251880 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS CELLEX C309

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR