BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3964308 · Received June 19, 2014

    Report

    Report Number
    2523595-2014-00174
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 8, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS INVESTIGATION, NO TRENDS WERE OBSERVED FOR THIS EVENT TYPE. THERE ARE CURRENTLY TWO CAPA'S OPENED - (B)(4) - TO INVESTIGATE PRESSURE DOME MEMBRANE LEAK. THE PRODUCT HAS NOT BEEN RETURNED FOR FURTHER ANALYSIS, THEREFORE IT CANNOT BE DETERMINED IF PRODUCT MET SPECIFICATION. COMPLAINTS OF THIS NATURE ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. SERVICE ORDER NUMBER (B)(4) DISPATCHED AND COMPLETED. CAPA (B)(4) IS CURRENTLY OPENED TO INVESTIGATE LATE REPORTING. (B)(4).

    Description of Event or Problem · 1

    REPORTED BY EMAIL FROM A CLINICAL SERVICE SPECIALIST WHO WAS OUT ON THE FIELD: CUSTOMER ASKED A FIELD ENGINEER (FE) TO CHECK PRESSURE SENSORS BECAUSE A BLOOD LEAK AT THE COLLECT PRESSURE. SERVICE ORDER WAS DISPATCHED. MORE INFORMATION HAS BEEN RETRIEVED FROM THE CUSTOMER ON (B)(4) 2014 WHO CONFIRMED THE EVENT TOOK PLACE ON (B)(6) 2014. TREATMENT IN DOUBLE NEEDLE MODE. DUE TO AN AIR DETECTED ALARM, NURSE MANIPULATED THE KIT AND BROKE THE COLLECT AND RETURN PRESSURE DOMES, CAUSING A BLOOD LEAK OVER THE PUMP DECK. THE NURSE CLEANED THE SENSORS AND INFORMED THE PHYSICIAN, CHIEF OF THE DEPARTMENT TO CONTACT THE SERVICE ASKING FOR A FE TO CHECK THE INSTRUMENT. AFTER HAVING CLEANED, A NEW KIT WAS INSTALLED AND A NEW TREATMENT WAS COMPLETED WITHOUT FURTHER PROBLEM. PATIENT WAS IN STABLE CONDITION. THE PRODUCT HAS NOT BEEN RETURNED FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359643 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1