BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 4152322 · Received October 3, 2014

    Report

    Report Number
    2523595-2014-00262
    Event Type
    Malfunction
    Date Received
    October 3, 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
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW OF LOT C320 WAS CONDUCTED. THERE WAS ONE NONCONFORMANCE ASSOCIATED WITH THIS TYPE OF FAILURE FOR THIS MANUFACTURING LOT (INC17048 DRIVE TUBE DELAMINATION). MANUFACTURING PROCEDURE BOUNDS THE FAILURE BY ADDITIONAL TESTING OF PROCEDURAL KITS WHERE THE FAILURE HAS OCCURRED. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, (B)(4): COLLECT PRESSURE AND DRIVE TUBE LEAK/BREAK. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. CAPA (B)(4) WAS INITIATED FOR COMPLAINT CATEGORY, DRIVE TUBE LEAK/BREAK. SERVICE ORDER, (B)(4), FEEDBACK: THE SERVICE TECHNICIAN CLEANED UP THE BLOOD SPILL AND SPECIAL ORDERED THE BOWL HOLDER ASSEMBLY. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. ANALYSIS OF THE RETURNED KIT AND PICTURES IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THIS ANALYSIS IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A DRIVE TUBE LEAK DURING BUFFY COAT COLLECTION AT 1500 ML WHOLE BLOOD PROCESSED. THE CUSTOMER ABORTED THE TREATMENT PROCEDURE AND DID NOT RETURN ANY BLOOD/PRODUCTS TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE CUSTOMER STATED NO ONE WAS HARMED OR SPLASHED DUE TO THE DRIVE TUBE BREAK SINCE THE DRIVE TUBE BREAK AND FLUIDS WERE CONTAINED WITHIN THE CENTRIFUGE. THE CUSTOMER STATED THAT THERE WERE NO ALARMS DURING PRIME. THE CUSTOMER STATED THEY HAD ONE COLLECT PRESSURE ALARM DURING THE PROCEDURE OR RIGHT BEFORE THE DRIVE TUBE BREAK, BUT THEY CLEARED THE ALARM BY FLUSHING THE ACCESS LINE. THE CUSTOMER STATED THERE WAS NO CLOTTING OR OCCLUSIONS NOTED IN THE KIT. SERVICE ORDER, (B)(4), WAS GENERATED. THE KIT AND PICTURES WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617277 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX LNR THERAKOS, INC. C320-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR