BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYETEM

    MDR report key: 4172878 · Received October 10, 2014

    Report

    Report Number
    2523595-2014-00278
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C337 WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET RELEASE REQUIREMENTS. A REVIEW OF LOT C337 SHOWS NO TRENDS. A REVIEW OF THE COMPLAINT CATEGORIES SHOWS NO TREND FOR PRESSURE DOME MEMBRANE LEAK OR ALARM #18: SYSTEM PRESSURE. AT THE TIME OF THE INVESTIGATION, NO TREND WAS DETECTED FOR PRESSURE DOME MEMBRANE LEAK OR ALARM #18: SYSTEM PRESSURE. CAPA'S (B)(4) AND (B)(4) WERE INITIATED FOR COMPLAINT CATEGORY PRESSURE DOME MEMBRANE LEAK. ALARM #18: SYSTEM PRESSURE WAS INVESTIGATED THROUGH CAPA (B)(4). CAPA (B)(4) WAS CLOSED AS EFFECTIVE. SERVICE ORDER (B)(4): TECHNICIAN PERFORMED CHECKOUT. TECHNICIAN REMOVED PUMP HEADS AND RE-LUBRICATED AFTER CLEANING, CALIBRATED PRESS TRANS AND CALIBRATED LOAD CELLS. INSTRUMENT TESTED AND NO ERRORS WERE FOUND. THE PRODUCT WAS NOT RETURNED FOR FURTHER ANALYSIS; THEREFORE. IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECS. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED THROUGH THE CAPA/CONTINUOUS IMPROVEMENT PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BLOOD LEAK AT THE SYSTEM PRESSURE MEMBRANE DURING PURGE AIR PHASE. CUSTOMER STATED THERE WERE NO ALARMS DURING PRIME. SYSTEM PRESSURE ALARM OCCURRED DURING TREATMENT, CUSTOMER RESET THE ALARM, AND THEN BLOOD WAS NOTED AROUND THE SYSTEM PRESSURE MEMBRANE. TREATMENT WAS ABORTED. PT WAS STABLE. PRODUCT WILL NOT BE RETURNED. SERVICE ORDER (B)(4) WAS DISPATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642979 THERAKOS CELLEX PHOTOPHERESIS SYETEM CELLEX LNR THERAKOS, INC. C337-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR