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

Catalog Number	4122201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440)
Date of Event	12/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article "peripheral venous access for low-volume centrifugal plasma exchange to treat patients with liver disorders" by janeela, a.M., chellaiya, g.K., thomas, r., bansal, a., kumar, s., sunderraj, g., jayaraman, s., kumar, s.E., alexander, v., david, v.G., varughese, s., daniel, d., nair, s.C., eapen, c.E., goel, a., & zachariah, u.G.Background/aims: centrifugal plasma exchange (plex), by virtue of low blood flow rates, can be performed via peripheral venous access.This study aims to assess the utilization, safety, and efficiency of low-volume centrifugal plasma exchange via peripheral venous access (p-plex)in liver disease patients.Methods: this retrospective cohort study compared patients with liver disease who underwent low-volume centrifugal p-plex (2019¿2024) with syndrome-matched patients who underwent plasma exchange via central venous access (c-plex).Data on plex procedure, venous access, and extraction efficiency for molecules of interest were noted.Results: of 448 liver disease patients who underwent centrifugal low-volume plex, 81 patients (18.1%) who underwent p-plex (m: 60; age: 37 "[29.5¿46.5]" years; median, interquartile range) were compared with 81 syndrome-matched patients who underwent c-plex (m: 62; age: 37 "[29.5¿46.5]" years; acute-on-chronic liver failure: 44, acute liver injury/acute liver failure: 21, others: 20).Targeted p-plex sessions were completed in 67 of 81 (82%).P-plex access was mostly 18-g (n = 64/72 for inlet/return)in antecubitalfossa.Thirteen of 81 (16%) p-plex patients required access change to cplex.Procedure time was longer in p-plex group (105 "[82.5¿120]" min) than in the c-plex group (75 "[60¿91.3]" min, p value< 0.001) due to lower flow rates in p-plex.When controlled for exchange volumes and baseline values, extraction efficiency of bilirubin (p-plex: 34.3% "[21.2¿42.6]", c-plex: 27.1% "[10.3¿41.7]"; p value: 0.14) and von willebrand factor antigen (p-plex: 36.1% "[21.8¿46.8]", c-plex: 45.6% "[32.8¿58.3]"; p value: 0.19) were similar in both groups.Plex was performed in the ward (in high monitoring area) in majority of patients in the p-plex group (73 "[90.1%]") and in the high-dependency unit (43 "[53.1%]") in the c-plex group.Lower linerelated complications with p-plex (2/81) vis-a-vis c-plex (9/81, p-value: 0.03) were noted.Conclusion: in this report, low-volume centrifugal plex to treat liver disease was performed via peripheral venous access in 18% of patients.P-plex was done in the ward, with similar efficiency and better line-related safety; however, the plex duration was prolonged by 30 min.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 this report is being filed due to patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.

• Brand Name: Spectra Optia
• Common Device Name: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): Terumo BCT; lakewood CO 80215
• Manufacturer (Section G): Terumo BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: kristi edgington ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 25843289
• Report Number: 1722028-2026-00105
• Device Sequence Number: 21392840
• Product Code: LKN
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• 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): 07/16/2026

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: 4122201
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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