BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PROCEDURAL KIT

    MDR report key: 3912015 · Received May 29, 2014

    Report

    Report Number
    3912015
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 23, 2014
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE TREATING THIS PATIENT WITH ECP - HAD #45 - RED CELL PUMP ALARM AT 335ML, 1307ML & 1342ML WBP. DECREASED COLLECT RATE TO 25ML/MIN & RETURN RATE TO 30ML/MIN. AFTER 3RD ALARM - LOWERED WBP TO 1307ML TO INITIATE EARLY BUFFY COLLECTION. REPORTED TO THERAKOS WHO DID NOT WANT THE KIT SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316337 CELLEX PROCEDURAL KIT KIT, SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS * C301 / 624

    Patients

    Seq Age Sex Outcome Treatment
    1 *