BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOPHERESIS PROCEDURAL KIT

    MDR report key: 1941631 · Received December 20, 2010

    Report

    Report Number
    1941631
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 20, 2010
    Manufacturer
    THERAKOS CELLEX
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THERE WAS A DELAY IN THE PROCEDURE. TWO DISPOSABLE KITS WERE USED. A PRIME TEN TYPE ERROR WAS NOTED MULTIPLE TIMES BY THE USER. IT WAS RELATED TO SCALE CALIBRATION. THE PROCEDURE WAS ABORTED TWICE, BUT SUCCESSFUL ON THE THIRD ATTEMPT. THERE WAS NO PATIENT HARM. WE ARE AWAITING A RESPONSE FROM THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOPHERESIS PROCEDURAL KIT PHOTOPHERESIS PROCEDURAL KIT X2 LNR THERAKOS CELLEX * Y303

    Patients

    Seq Age Sex Outcome Treatment
    1 *