MAUDE Adverse Event Report: Terumo BCT Spectra Optia; SPECTRA OPTIA EXCHANGE SET

Catalog Number	10220
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.The objective of the study was to evaluate whether centrifugal plasma exchange (cplex) combined with low-dose prednisolone improves 1-year transplant-free survival in patients with very severe alcoholic hepatitis (vsah) compared with: standard medical treatment (smt), andmembrane plasma exchange (mplex) plus low-dose steroid the spectra optia apheresis system was the device used to perform centrifugal plasma exchange (cplex).The comparator mplex procedures were performed using a fresenius dialysis-based system.Three patients developed bacteremia while undergoing or shortly after plasma exchange, while one patient experienced a minor bleed at the vascular access site.Management included antibiotics and discontinuation of both plasma exchange and steroid therapy.One patient later underwent liver transplantation approximately 60 days later.Two patients died within 1 to 3 weeks after diagnosis of bacteremia, reflecting the severity of their underlying liver disease.The authors acknowledged several limitations including retrospective study design subject to inherent selection and treatment bias.Small sample size particularly in the cplex and mplex groups.Unequal steroid use; patients receiving smt did not receive steroids, making it difficult to completely separate the effect of cplex from the effect of low-dose prednisolone.Clinicial-directed plex duration ¿ no predefined objective criteria for determining the number of plasma exchange sessions.Follow-up partly conducted by telephone, some outcome data were collected through telephonic follow-up.And finally, potential unmeasured confounders; despite propensity-score matching, residual confounding cannot be excluded.Investigation is in process, a follow-up report will be provided.Citation: kumar, s.E., chellaiya, g.K., singh, k.A., karuppusami, r., daniel, d., david, v.G., nair, s.C., varughese, s., mammen, j., elias, e., eapen, c.E., zachariah, u.G., & goel, a.(2024).Centrifugal technique of plasma exchange and low-dose steroid to treat very severe alcoholic hepatitis patients: a retrospective analysis.Indian journal of gastroenterology, 44(3), 345¿354.Https://doi.Org/10.1007/s12664-024-01569-3.
Event or Problem Description
Per journal article "centrifugal technique of plasma exchange and low-dose steroid to treat very severe alcoholic hepatitis patients: a retrospective analysis" by kumar, s.E., chellaiya, g.K., singh, k.A., karuppusami, r., daniel, d., david, v.G., nair, s.C., varughese, s., mammen, j., elias, e., eapen, c.E., zachariah, u.G., & goel, a.Backgroundlow-volume plasma exchange (plex) and low-dose steroid improve survival in severe alcoholic hepatitis.We aimed to compare one-year survival of very severe alcoholic hepatitis (vsah) patients treated with centrifugal plex (cplex), membrane plex (mplex) or standard medical treatment (smt).Methodswe retrospectively analyzed survival in consecutive vsah patients treated at our department from november 2017 to september 2021.Plex patients received low-volume plex along with low-dose steroid (tab.Prednisolone 10 mg or 20 mg daily).To adjust for baseline differences between the three treatment (cplex, mplex or smt) groups, propensity score (ps) matching was done.Acute-on-chronic liver failure (aclf) was defined as per european association for the study of the liver (easl).The primary study outcome was one-year transplant-free survival of ps-matched vsah patients treated with cplex compared to smt.Resultsof 101 plex-eligible vsah patients, 30 patients were treated with cplex, 21 with mplex and 50 with smt.On comparing 30 ps-matched patients each in the cplex group vs.The smt group, transplant-free survival in the cplex group was 86.7% at one month, 70% at three months and 52.4% at one year and in the smt group was 33.3% at one month, 23.3% at three months and 16.7% at one year with hazard ratio (hr "[95% ci]") in favor of the cplex group (0.29 "[0.15¿0.56]", p < 0.001).Total 21 patients each (ps-matched) in cplex and mplex groups were compared and one-year survival was better with cplex (0.33 "[0.16¿0.69]", p = 0.001).The sub-group analysis of vsah (ps-matched cohort) patients with aclf also showed better survival with cplex compared to smt (0.38 "[0.17¿0.83]", p = 0.003) and compared to mplex (0.43 "[0.17¿0.95]", p = 0.03).Conclusionbetter one-year transplant-free survival was noted among ps-matched vsah patients treated with cplex (and low-dose steroid) compared to smt (without steroid).Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events the collection set is not available for return because it was discarded by the customer.

• Brand Name: Spectra Optia
• Common Device Name: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): Terumo BCT; lakewood CO 80215
• Manufacturer (Section G): BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: kristi edgington ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 25883689
• Report Number: 1722028-2026-00109
• Device Sequence Number: 21336448
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

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: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown