BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 6183438 · Received December 16, 2016

    Report

    Report Number
    2523595-2016-00278
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 16, 2016
    Manufacturer
    THERAKOS, INC
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. A BATCH RECORD REVIEW OF KIT LOT E349 WAS REVIEWED. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, TUBING LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THIS ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. AT THE TIME OF THIS REPORT, THE ANALYSIS OF THE RETURNED KIT PHOTOS IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS OF THE KIT PHOTOS IS COMPLETE . (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A PHOTO ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT. A REVIEW OF THE PHOTOS CONFIRMED THE LEAK. HOWEVER, THE LOCATION OF THE LEAK COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. NEITHER THE CAUSE NOR THE ROOT CAUSE FOR THE LEAK COULD BE DETERMINED BASED ON THE REVIEW AS NO MANUFACTURING DEFECTS WERE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY RELATED NONCONFORMANCES. NO FURTHER ACTION REQUIRED. THIS INVESTIGATION IS NOW COMPLETE. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A TUBING LEAK AT THE COLLECT PUMP TUBING SEGMENT AFTER 1241ML OF WHOLE BLOOD PROCESSED. THE CUSTOMER STATED THAT THE TREATMENT WAS ABORTED WITH NO BLOOD/PRODUCTS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER STATED THAT THERE WERE NO ALARMS PRIOR TO THE LEAK. THE CUSTOMER REPORTED THAT THEY HAD NO TROUBLE LOADING THE KIT ONTO THE INSTRUMENT. PHOTOS WERE SUBMITTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834101 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS, INC NOT APPLICABLE E349 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR