BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 21595922 · Received March 13, 2025

    Report

    Report Number
    1722028-2025-00058
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    January 1, 2025
    Report Date
    March 13, 2025
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583610002
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE THIS WAS A JOURNAL PUBLICATION FROM 2024 TO EVALUATE THE EFFICACY AND SAFETY OF EXTRACORPOREAL PHOTOPHERESIS AS A USEFUL THERAPEUTIC TOOL FOR T CELL-MEDIATED REJECTION IN RENAL TRANSPLANTATION, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DISPOSABLE LOT HISTORY SEARCH COULD NOT BE CONDUCTED. SINCE THIS WAS A JOURNAL PUBLICATION FROM 2024 TO EVALUATE THE EFFICACY AND SAFETY OF EXTRACORPOREAL PHOTOPHERESIS AS A USEFUL THERAPEUTIC TOOL FOR T CELL-MEDIATED REJECTION IN RENAL TRANSPLANTATION, THE LOT NUMBERS WERE NOT REQUESTED; THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. AN INVESTIGATION WAS CONDUCTED FOR A JOURNAL ARTICLE THAT REFERENCES TERUMO BCT PRODUCT. JOURNAL ARTICLE, TITLED ¿EXTRACORPOREAL PHOTOPHERESIS, A THERAPEUTIC ALTERNATIVE FOR T CELL-MEDIATED REJECTION IN RENAL TRANSPLANTATION¿ BY DE LARA GIL ET AL WAS REVIEWED WITH PRIMARY PURPOSE OF SCREENING FOR ALLEGATIONS OF TERUMO BCT DEVICE CAUSING OR CONTRIBUTING TO DEATH/INJURY OR DEVICE MALFUNCTIONS. SUMMARY OF TERUMO BCT PRODUCT IN RELATION TO THE JOURNAL ARTICLE: THE INCIDENCE OF T-CELL MEDIATED REJECTION (TCMR) IN RENAL TRANSPLANTATION HAS DECREASED WITH THE ADVENT OF BETTER IMMUNOSUPPRESSANTS (IS), BUT IT STILL OCCURS AND RESULTS IN LOWER RENAL GRAFT SURVIVAL. TCMR RESPONDS TO METHYLPREDNISOLONE (MPL) BOLUSES IN 60% TO 70% OF CASES. IN CASE OF CORTICORESISTANT TCMR OR SEVERE REJECTION, POLYCLONAL ANTI-T-LYMPHOCYTE ANTIBODIES (ATGS) ARE USED. BUT IN CASE OF RESISTANCE OR CONTRAINDICATION OF ATG [1], AS IN THE CASE OF THE TWO PATIENTS WE PRESENTED (THE 2 PATIENTS HAD CONTACT WITH A PATIENT INFECTED WITH CORONA VIRUS DISEASE [COVID+]), EXTRACORPOREAL PHOTOPHERESIS (ECP) THERAPY WAS PROPOSED AS AN ALTERNATIVE, THEY CONSENTED AND IT WAS STARTED AFTER PARTIAL IMPROVEMENT OF THEIR RENAL FUNCTION WITH STEROID BOLUSES. ECP IS AN IMMUNE REGULATORY TREATMENT THAT INVOLVES THE REMOVAL OF IMMUNE CELLS FROM THE PATIENT¿S PERIPHERAL BLOOD. THESE CELLS ARE EXPOSED TO A PHOTOACTIVE AGENT, 8-METHOXYPSORALEN, WITH SUBSEQUENT ULTRAVIOLET-A RADIATION, AND THEN REINJECTED. IT IS AN IMMUNOMODULATORY THERAPY THAT HAS PROVEN EFFICACY IN SEVERAL T-CELL-MEDIATED AND AUTOIMMUNE DISEASES. IT IS ALSO RECOMMENDED BY THE AMERICAN SOCIETY OF APHERESIS AS A THERAPEUTIC OPTION FOR THE PROPHYLACTIC TREATMENT OF CARDIAC REJECTION AND BY THE INTERNATIONAL SOCIETY OF HEART AND LUNG TRANSPLANTATION TO TREAT RESISTANT OR RECURRENT PULMONARY REJECTION. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EFFECTS RELATED TO VASCULAR ACCESS ARE A FREQUENT CONCERN. HEMORRHAGE OR PNEUMOTHORAX OR BOTH MAY COMPLICATE CENTRAL VENOUS CATHETER (CVC) INSERTION, WHILE THROMBOSIS AND INFECTION ARE THE MOST FREQUENTLY OBSERVED COMPLICATIONS OF PROLONGED CENTRAL VENOUS ACCESS. DURING A DRESSING CHANGE, THE SITE SHOULD BE CLEANED AND OBSERVED FOR SIGNS OF INFECTION SUCH AS REDNESS, SWELLING, DRAINAGE, AND FOUL ODOR. IF AN INFECTION IS SUSPECTED, CVC REMOVAL SHOULD BE CONSIDERED, AND THE PATIENT SHOULD BE TREATED FOR INFECTION AS APPROPRIATE. THE CAUSE OF A CVC FLOW PROBLEM MAY SOMETIMES BE DIFFICULT TO DETERMINE, ALTHOUGH PATIENT REPOSITIONING WILL SOMETIMES IMPROVE FLOW. A COMMON SITUATION IS THAT THE CVC CAN BE FLUSHED WITHOUT RESISTANCE BUT DOES NOT YIELD BLOOD RETURN; THIS SCENARIO MAY BE THE RESULT OF KINKING, POOR POSITIONING, INTRALUMINAL CLOTS, OR VENOUS THROMBOSIS. BLOCKED CVCS CAN SOMETIMES BE CLEARED WITH A FIBRINOLYTIC AGENT SUCH AS TPA. THE PLACEMENT OF A CVC IS CONSIDERED BY SOME TO BE THE GREATEST RISK RELATED TO THE APHERESIS PROCEDURES, AND IT SHOULD BE AVOIDED IF THE PROCEDURE CAN BE PERFORMED USING PERIPHERAL IV. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE PARTIAL THROMBOSIS OF THE PATIENT 2¿S AVF. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT IS LIKELY DUE TO ONE OR A COMBINATION OF THE POSSIBLE CAUSES LISTED BELOW: * PATIENT¿S UNDERLYING DISEASE AND/OR PHYSIOLOGY. * ACCESS WAS NOT ADEQUATELY MAINTAINED CITATION: DE LARA GIL, M., MUÑOZ, M. G., DE LARA GIL, E., BLANQUER, M., VIÑAS, S. L., CARAVACA, F. M., LUJÁN, I. S., & ROMERO, J. B. C. (2025). EXTRACORPOREAL PHOTOPHERESIS, A THERAPEUTIC ALTERNATIVE FOR T CELL-MEDIATED REJECTION IN RENAL TRANSPLANTATION. TRANSPLANTATION PROCEEDINGS. HTTPS://DOI.ORG/10.1016/J.TRANSPROCEED.2024.11.028.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE, ¿EXTRACORPOREAL PHOTOPHERESIS, A THERAPEUTIC ALTERNATIVE FOR T CELL-MEDIATED REJECTION IN RENAL TRANSPLANTATION¿ BY DE LARA GIL ET AL.,T-CELL MEDIATED REJECTION (TCMR) IN RENAL TRANSPLANTATION, ALTHOUGH REDUCED BY BETTER IMMUNOSUPPRESSANTS, STILL IMPACTS GRAFT SURVIVAL. THE ARTICLE STATED THAT ONE WEEKLY CYCLE OF EXTRACORPOREAL PHOTOPHERESIS (ECP) WAS PERFORMED IN THE FIRST MONTH, AND THEN BIWEEKLY. PATIENT 2 UTILIZED A SPECTRA OPTIA DEVICE FOR TREATMENT, HOWEVER ECP WAS DISCONTINUED 3 MONTHS AFTER INITIATION DUE TO PARTIAL THROMBOSIS (BLOOD CLOT) OF THE ARTERIOVENOUS FISTULA (AVF). AFTER ANGIOPLASTY AND THROMBECTOMY, THE AVF WAS PERMEABLE AND THE ECP WAS RESTARTED 5 WEEKS AFTER THE PREVIOUS CYCLE, EVERY 2 WEEKS. TOLERANCE TO THE SESSIONS WAS EXCELLENT WITHOUT ANY SYMPTOMS. THE ONLY COMPLICATION WAS PARTIAL THROMBOSIS OF THE AVF IN PATIENT 2. THERE WERE NO INFECTIONS. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS WAS A JOURNAL PUBLICATION FROM 2024 TO EVALUATE THE EFFICACY AND SAFETY OF EXTRACORPOREAL PHOTOPHERESIS AS A USEFUL THERAPEUTIC TOOL FOR T CELL-MEDIATED REJECTION IN RENAL TRANSPLANTATION. A REQUEST FOR FURTHER SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE BECAUSE THERE ARE MANY MONTHS BETWEEN COLLECTION OF DATA, TO PEER REVIEW, TO FINAL PUBLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884251 SPECTRA OPTIA APHERESIS SYSTEM SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 05020583610002

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Other