BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    MDR report key: 2765910 · Received September 25, 2012

    Report

    Report Number
    2523595-2012-00029
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT FILE FOR Y723 WAS PERFORMED. THIS LOT MET ALL RELEASE REQUIREMENTS. THE KIT WAS NOT RETURNED FOR FURTHER INVESTIGATION, THEREFORE, THE COMPLAINT CANNOT BE VERIFIED. OCD FIELD ENGINEER ARRIVED AT SITE FOR CENTRIFUGE LID ISSUE. FE ADJUSTED THE COVERS TO CORRECT THE ISSUE. HINGE SCREWS WERE TIGHTENED. INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING CYCLE 4, A BLOOD LEAK ALARM OCCURRED DUE TO SEAL FAILURE. CUSTOMER HAD STATED THAT THE CENTRIFUGE LID WAS DIFFICULT TO CLOSE/TIGHTEN POSSIBLY PLACING EXTRA FORCE ON THE BOWL AND CAUSING A POSSIBLE SEAL FAILURE. THE TREATMENT WAS ABORTED; NO MANUAL RETURN. TOTAL BLOOD LOSS WAS 300 ML. N F/U FLUIDS OR LABS DRAWN POST EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS XTS PHOTOPHERESIS SYSTEM UVAR XTS ECP SYSTEM LNR THERAKOS 6660 Y723

    Patients

    Seq Age Sex Outcome Treatment
    1