BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1840464 · Received September 8, 2010

    Report

    Report Number
    1840464
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 8, 2010
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A PHOTOPHERESIS TREATMENT. SOON AFTER INITIATING PROCEDURE, TWO ALARMS WERE ACTIVATED. THE NURSE RESET THE INSTRUMENT AND CONTINUED WITH THE PROCEDURE. A THIRD ALARM WAS ACTIVATED AND NOW SPECIFIED THAT THERE WAS A BLOOD LEAK IN THE SYSTEM. THE PROCEDURE WAS STOPPED. AN INVESTIGATION OF THE ALARM IDENTIFIED A LEAK IN THE BOWL CHAMBER AND THE PROCEDURE WAS ABORTED. APPROXIMATELY 100-120ML OF BLOOD REMAINED IN THE TUBING/BOWL AND COULD NOT BE RETURNED TO PT. AN ASSESSMENT OF THE PT FOUND NO ADVERSE EFFECTS DUE TO THE ABORTED PROCEDURE. THE INITIAL HEMOGLOBIN WAS 12.5G/DL AND THE PT HAD NO COMPLAINTS AFTER THE PROCEDURE WAS ABORTED. THIS IS NOT A PROBLEM WITH THE DEVICE, BUT THE KIT. OCCASIONAL PROBLEMS HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PHOTOPHERESIS LNR THERAKOS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *