BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 3770433 · Received February 18, 2014

    Report

    Report Number
    2523595-2014-00046
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 17, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH RECORD REVIEW OF LOT B343 WAS CONDUCTED. THERE WERE NO NON CONFORMANCES RELATED TO THIS LOT. LOT MET RELEASE REQUIREMENTS. TRENDS HAVE BEEN REVIEWED ON A LOT BY LOT BASIS FOR THIS COMPLAINT CATEGORY AND NO TREND HAS BEEN DETECTED FOR THIS SPECIFIC LOT. SERVICE ORDER (B)(4) COMPLETED: SERVICE ENGINEER DISINFECTED UNIT, PERFORMED SYSTEM CHECKOUT AND WATER TREATMENT. INSTRUMENT PERFORMS PER SPECIFICATION. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED BY CUSTOMER FOR INVESTIGATION AND THE EVALUATION FOR THE PHOTOS PROVIDED BY THE CUSTOMER STILL PENDING; THEREFORE, NO ROOT CAUSE COULD BE DETERMINED AT THIS TIME SINCE INVESTIGATION IS STILL IN PROGRESS. AS A PREVENTIVE ACTION, (B)(4) HAS BEEN INITIATED TO INVESTIGATE CELLEX SYSTEM CENTRIFUGE BOWL FAILURES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BOWL BREAK THAT OCCURRED DURING TREATMENT. NAME AND FUNCTION OF COMPLAINANT: SAME AS REPORTER. CUSTOMER CALLED TO REPORT A BOWL BREAK DURING TREATMENT. CUSTOMER STATED IT WAS RIGHT BEFORE BUFFY COAT COLLECTION PHASE. CSS ASKED THE CUSTOMER IF ANY OTHER ALARMS OCCURRED DURING THE PROCEDURE. CUSTOMER STATED THEY RECEIVED 2 RED CELL PUMP ALARMS DUE TO LOW INTERFACE AND PATIENT ABNORMAL RED CELL MORPHOLOGY. CUSTOMER STATED IT APPEARED THE BEARING FAILED AND THERE WAS BEARING GREASE IN THE CENTRIFUGE. CUSTOMER IS REQUESTING KIT CREDIT AND SERVICE ON THE INSTRUMENT FOR THE SPILL. SERVICE ORDER (B)(4) WAS CREATED TO CHECK INSTRUMENT. NO KIT WAS RETURNED FOR INVESTIGATION, BUT CUSTOMER PROVIDED PHOTOS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102302 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. 6661 B343 KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR