BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PROCEDURAL KIT

    MDR report key: 3861258 · Received May 29, 2014

    Report

    Report Number
    3861258
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 5, 2014
    Report Date
    May 29, 2014
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT BEING TREATED IN ECP ON CELLEX MACHINE AND KIT NUMBER B351/1031 WITH AN EXPIRATION DATE 12/01/2015. RED BLOOD CELL ALARM X2 WITH KIT NOT PROPERLY MODULATING. PHYSICAL INTERFACE TOO HIGH IN BOWL AND INTERFACE NUMBER ON SCREEN TOO LOW. TREATMENT ENDED AFTER TROUBLE SHOOTING AND TALKING WITH PATIENT. THERAKOS NOTIFIED OF PROBLEMS WITH KIT AND RGA NUMBER ISSUED. KIT SEQUESTERED FOR BIO-MED. THERAKOS DID NOT WANT KIT BACK. ALL PATIENT'S BLOOD RETURNED. NEW KIT PRIMED AND TREATMENT RESTARTED.======================MANUFACTURER RESPONSE FOR DISPOSABLES, CELLEX (PER SITE REPORTER).======================MANUFACTURER DID NOT WANT KIT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317224 CELLEX PROCEDURAL KIT KIT, SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS, INC CELLEX UNK
    317225 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS, INC CELLEX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR