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 Code	Adult Respiratory Distress Syndrome (1696)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article "plasma exchange with corticosteroids as a rescue therapy for severe prolonged cholestasis in acute viral hepatitis" by taneja, s., mehtani, r., ganesh, c.P., rose, s., balaraja, s., kannupriya, rathi, s., de, a., lamba, d., verma, n., premkumar, m., hans, r., sharma, r.R., & duseja, a.Abstract: background and aims:prolonged cholestasis after acute viral hepatitis (avh) complicates <1% of patients.The treatment includes the use of anti-pruritic medications in a stepwise manner.This study assessed the role of plasma exchange (plex) with corticosteroids on severe prolonged cholestasis.Methods:retrospective analysis of patients with avh and prolonged cholestasis was conducted.Prolonged cholestasis was defined as jaundice for >6 weeks with peak serum bilirubin >10 mg/dl, in the absence of haemolysis and renal failure with alanine transferase level below 500u/l.A combination of centrifugal plex with corticosteroids was offered if there was no response to anti-pruritic medications.A control group, which received only anti-pruritic medications, was included for comparison.Results:fifty-nine patients, predominantly males (90%; n = 53) were included.Most common etiology was hav (n = 56; 94.9%) followed by hev (n = 3; 5.1%).Despite more severe disease, (higher visual analogue scale (vas) - 9 "[9-9]" vs 8 "[7¿8]", p < 0.001 and higher bilirubin - 30.6 ± 4.1 vs 27.3 ± 7.1 mg/dl, p = 0.03), bilirubin reduction was faster in combination group.Percentage reduction in bilirubin at week 1 and week 4 was 43.6% ± 7.9% and 93.8% ± 1.6% in the combination group vs 37.9% ± 12.9% and 89.4% ± 4.4% in the conservative group (p = 0.04 and < 0.001, respectively).Median time to symptom improvement was less in the combination group (25 "[22¿27]" days vs 42 "[38¿48]" days; p < 0.001 in conservative group).Conclusion:plex combined with low-dose oral steroids results in significant improvement in prolonged cholestasis and can be considered as an effective rescue therapy in patients who do not respond to standard anti-pruritic medications 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.
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.Citation: taneja, s., mehtani, r., ganesh, c.P., rose, s., balaraja, s., kannupriya, rathi, s., de, a., lamba, d., verma, n., premkumar, m., hans, r., sharma, r.R., & duseja, a.(2025).Plasma exchange with corticosteroids as a rescue therapy for severe prolonged cholestasis in acute viral hepatitis.Journal of clinical and experimental hepatology, 15(6), 102594.Https://doi.Org/10.1016/j.Jceh.2025.102594.

• 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: 25883535
• Report Number: 1722028-2026-00108
• Device Sequence Number: 15995275
• 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): 07/20/2026

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: 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: Not provided
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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