BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 10648612 · Received October 8, 2020

    Report

    Report Number
    2523595-2020-00107
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 6, 2020
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT KIT, SMART CARD, AND A PHOTOGRAPH WAS RETURNED FOR EVALUATION. A REVIEW OF THE PROVIDED PHOTOGRAPH VERIFIES THE PUMP TUBING ORGANIZER (PTO) LEAK AS BLOOD IS SEEN LEAKING FROM THE LOWER RIGHT CORNER OF THE PTO. THE SMART CARD DATA SHOWS THE TREATMENT PROCEEDED THROUGH THE PHOTOACTIVATION PHASE OF THE PROCEDURE UNTIL THE OPERATOR ABORTED THE TREATMENT. THE PTO WAS THE ONLY COMPONENT OF THE KIT RETURNED FOR ANALYSIS. EXAMINATION OF THE RETURNED PTO FOUND DRIED BLOOD ON THE LOWER RIGHT CORNER OF THE PTO AS SEEN IN THE PROVIDED PHOTOGRAPH. THE PTO WAS PRESSURE TESTED TO CHECK FOR LEAKS UNDER BOTH POSITIVE AND NEGATIVE PRESSURE AND NO LEAKS WERE IDENTIFIED. A MATERIAL TRACE OF THE RELATED COMPONENTS USED TO BUILD LOT J108 SHOWED NO RELATED NON-CONFORMANCES. THE DEVICE HISTORY RECORD (DHR) REVIEW DID NOT RESULT IN ANY RELATED NON-CONFORMANCES AND THIS KIT LOT PASSED ALL LOT RELEASE TESTING. THE PTO LEAK WAS VERIFIED BASED ON THE PROVIDED PHOTOGRAPH; HOWEVER, PRESSURE TESTING OF THE RETURNED PTO DID NOT RESULT IN A LEAK. THE CAUSE OF THE PTO LEAK WAS MOST LIKELY A WEAK WELD AT THE BLOOD FILTER IN THE PTO. THE ROOT CAUSE FOR THE WEAK WELD COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(4). P.T. (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION PUMP TUBING ORGANIZER (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 J108 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT J108 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 PHOTOGRAPH IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT THEY EXPERIENCED A PUMP TUBING ORGANIZER (PTO) LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A BLOOD LEAK WAS OBSERVED IN THE PUMP TUBING ORGANIZER NEXT TO THE BLOOD FILTER DURING THE PHOTOACTIVATION PHASE OF THE PROCEDURE. THE CUSTOMER CONTACTED THE PHYSICIAN WHO ADVISED TO COMPLETE THE TREATMENT AND RETURN BLOOD WITHIN THE KIT TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER RETURNED THE KIT AND A PHOTOGRAPH FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118323 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS, INC. NOT APPLICABLE 189

    Patients

    Seq Age Sex Outcome Treatment
    1