MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA APHERESIS SYSTEM

Catalog Number	61000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: SPECTRA OPTIA APHERESIS SYSTEM
• Common Device Name: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 21595922
• Report Number: 1722028-2025-00058
• Device Sequence Number: 12828406
• Product Code: LKN
• UDI-Device Identifier: 05020583610002
• UDI-Public: 05020583610002
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 61000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Unknown