BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS MACHINE AND DISPOSABLE SET

    MDR report key: 3121953 · Received May 15, 2013

    Report

    Report Number
    MW5030223
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 3, 2013
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING PHOTOPHERESIS TREATMENT USING CELLEX INSTRUMENT WITH DISPOSABLE TUBING SET. DURING THE PHOTOACTIVATION PERIOD THE OPERATOR NOTED THAT THE TREATMENT BAG WAS FILLING WITH SALINE. PROCEDURE ABORTED AFTER CONSULTING WITH THE MANUFACTURER. IT WAS IDENTIFIED BY THEIR REPAIR TEAM THAT THE DISPOSABLE TUBING WAS MIS-ROUTED INSIDE THE SET AT SECTION V5. THIS DEFECT CAUSED THE SALINE TO EMPTY INTO THE TREATMENT BAG CREATING THE POTENTIAL FOR FLUID OVERLOAD TO THE PATIENT. NO ACUTE HARM TO THE PT, BUT HE WAS UNABLE TO RECEIVE THE INTENDED TREATMENT. OUR APHERESIS CLINIC HAS HAD NUMEROUS INCIDENTS OF INSTRUMENT MALFUNCTION RELATED TO THE BOWL OPTIC SENSOR AND DISPOSABLE SETS. BOWL OPTIC SENSOR ON THE CELLEX PHOTOPHERESIS MACHINE REQUIRES FREQUENT RE-CALIBRATION TO MAINTAIN MANUFACTURER SPECIFICATIONS. A RECENT UPGRADE TO THE DEVICE WAS PERFORMED INCORRECTLY BY THE LOCAL FIELD ENGINEER. THIS WAS IDENTIFIED AND CORRECTED BY THE LEAD ENGINEER WHILE INVESTIGATING THIS MOST RECENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214509 CELLEX PHOTOPHERESIS MACHINE AND DISPOSABLE SET NONE LNR THERAKOS B304/839 SET

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other