BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 8232267 · Received January 9, 2019

    Report

    Report Number
    2523595-2019-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 10, 2018
    Report Date
    March 7, 2019
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION PTO LEAK. SINCE THIS REPORTABLE MALFUNCTION IS ONLY ASSOCIATED WITH THE KIT, THIS MDR WILL ONLY BE AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT G353 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT G353 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, PTO LEAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. AT THE TIME OF THIS REPORT, THE ANALYSIS OF THE RETURNED KIT AND PHOTOGRAPHS IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4). DATE OF REPORT: 01/09/2019.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT KIT AND PHOTOGRAPHS WERE RETURNED FOR ANALYSIS. A REVIEW OF THE CUSTOMER PROVIDED PHOTOGRAPHS SHOW EVIDENCE OF DRIED BLOOD ON THE LEFT SIDE OF THE RETURN FILTER IN THE PUMP TUBING ORGANIZER (PTO). THE PTO OF THE RETURNED KIT WAS PRESSURE TESTED AND CONFIRMED THE LEAK IN THE PTO FILTER. A BISECTION OF THE PTO FILTER WELD AT THE LEAK SOURCE IDENTIFIED THAT THE ENERGY DIRECTOR HAD NOT BEEN FULLY COLLAPSED DURING ULTRASONIC WELDING. AS A RESULT, THE ROOT CAUSE OF THE PTO FILTER LEAK WAS DUE TO A POOR WELD BETWEEN THE FILTER COVER AND THE BASE OF THE PTO DURING THE MANUFACTURING PROCESS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A PTO LEAK THAT WAS DISCOVERED WHEN THE KIT WAS REMOVED AFTER A COMPLETED TREATMENT. CUSTOMER STATED THAT THE PATIENT IS STABLE. THE CUSTOMER STATED THAT 1500 ML OF WHOLE BLOOD WAS PROCESSED. THE CUSTOMER STATED THAT THE KIT PRIMED WITH NO ISSUES. THE CUSTOMER STATED THERE WERE NO ALARMS DURING THE TREATMENT. THE CUSTOMER STATED THAT THEY NOTICED BUBBLES IN THE PTO FILTER DURING REINFUSION. THE CUSTOMER STATED THAT THEY SAW BLOOD ON THE PUMP DECK AFTER THE KIT WAS REMOVED. THE CUSTOMER RETURNED THE KIT AND PHOTOGRAPHS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23586 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS INC. NOT APPLICABLE G353 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1