BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3853658 · Received April 3, 2014

    Report

    Report Number
    2523595-2014-00094
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT B352 WAS PERFORMED AND THERE WERE NO NON CONFORMANCES ASSOCIATED WITH THIS LOT. NO TREND FOR COMPLAINT CATEGORY DRIVE TUBE LEAK/BREAK AT THE TIME OF INVESTIGATION. PENDING SERVICE ORDER. A PHOTO ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT. THE PHOTOS SHOWED A LEAK IN THE DRIVE TUBE. IT IS EVIDENT THAT THE LEAK WAS CAUSED BY THE TOP BEARING STOP DELAMINATING FROM THE DRIVE TUBE. THE DELAMINATION OF THE BEARING STOP IN THIS SCENARIO WOULD HAVE BEEN CAUSED BY THE PORTION OF THE BEARING STOP BEING UNBONDED TO THE DRIVE TUBE. THERAKOS CAPA (B)(4) AND HARMAC (B)(4) HAVE BEEN OPENED TO INVESTIGATE THE TRAPPED GASES OCCURRING DURING THE BEARING STOP MOLDING PROCESS. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. SHOULD A TREND ARISE, FURTHER ACTION WILL BE TAKEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT DRIVE TUBE LEAK DURING TREATMENT PROCEDURE AT 1100 ML WHOLE BLOOD PROCESSED. CUSTOMER STATED UPPER BEARING DRIVE TUBE LOOKED TWISTED AND BROKEN. CUSTOMER STATED THE BEARING WAS STILL IN THE BEARING HOLDER. CUSTOMER ABORTED PROCEDURE WITH NO RETURN OF BLOOD OR FLUIDS. CSS ASKED IF PT WAS OK, CUSTOMER STATED YES; PT WAS IN STABLE CONDITION. CSS ASKED IF THERE WERE ANY ALARMS DURING PRIME OR DURING THE PROCEDURE, CUSTOMER STATED THERE WERE NO ALARMS DURING PRIME OR DURING THE PROCEDURE. SERVICE NUMBER (B)(4) WILL BE DISPATCHED AS PER CUSTOMER REQUEST. PHOTOS WERE PROVIDED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203089 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR B352-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR