BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, PROCEDURAL, CELL EX, ECP

    MDR report key: 2494613 · Received February 27, 2012

    Report

    Report Number
    2494613
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 24, 2012
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AT THE START OF PRIMING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PROCEDURAL KIT ON THE CELL EX INSTRUMENT, WE HAD 5 ALARMS. THEY INVOLVED NUMBER 46 ACCELOROMETER. TROUBLE-SHOOTING INCLUDED: POWERING INSTRUMENT OFF AND ON; REMOVING AND RELOADING THE CENTRIFUGE BOWL AND DRIVE TUBE. WE WERE UNABLE TO CLEAR THE ALARM. THE KIT TO BE SENT TO BIOMED, THEN RETURNED TO THERAKOS FOR CREDIT. THE INSTRUMENT WAS SUCCESSFULLY PRIMED WITH ANOTHER KIT. WE ARE AWAITING A RESPONSE FROM THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PROCEDURAL, CELL EX, ECP CELL EX ECP PROCEDURAL KIT LNR THERAKOS * Z391/Z113/244

    Patients

    Seq Age Sex Outcome Treatment
    1 *