MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number	4122201
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, manufacture date and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Icitation: srivaths, p., monis, g.F., fernando, l.P., hendrickson, j.E., raval, j.S., jacquot, c., davis, k., wong, e., & yamada, c.(2025).Report of the asfa apheresis registry study on focal segmental glomerulosclerosis.Journal of clinical apheresis, 40(4).Https://doi.Org/10.1002/jca.70041.
Event or Problem Description
Per journal article "report of the asfa apheresis registry study on focal segmental glomerulosclerosis" by poyyapakkam srivaths, grace f.Monis, leonor p.Fernando, jeanne e.Hendrickson, jay s.Raval, cyril jacquot, keefe davis, edward wong, chisa yamad abstract focal segmental glomerulosclerosis (fsgs) is one of the causes of end-stage kidney disease.The etiology is not fully understood, and standardized treatments are not established.We created a registry on apheresis for post-transplant fsgs through the renal subcommittee in the research committee in the american society for apheresis (asfa), and here is our first report.Members of the renal subcommittee from seven centers in the united states contributed data collection on demographic, clinical course, and overall outcomes of patients with post-transplant recurrence of fsgs treated with therapeutic plasma exchange (tpe) between 2015 and 2020.The tpe data, including frequency and replacement fluid for tpe, are also investigated.The median age at diagnosis of fsgs and first transplantation among 26 patients was 12.7 and 21 years, respectively.The fsgs recurred at a median of 1 day after transplantation, and tpe was performed daily or every other day in the first month and continued at some frequency beyond a year in some cases.Most procedures used albumin as a replacement fluid and citrate anticoagulation, with 1¿1.5 plasma volumes exchange.Twelve patients had complete/partial remission by 6 months.The median urine protein/creatinine ratio improved from 4.47 to 1.4 mg/mg within 3 months, and egfr improved from 26 to 78 ml/min/1.73 m2 in a year after tpe started.The study revealed some uniformity in the prescription of tpe, primarily using albumin as replacement fluid and performing 1¿1.5 plasma volume exchanges.Observed complication rates were minimal.Tpe can be one of the treatments to consider in this condition.Most patients tolerated tpe well.There were two instances of allergic reactions with plasma replacement, two instances of suspected transfusion reactions, and three instances of asymptomatic hypocalcemia in the first 4 weeks of treatment.Most patients tolerated tpe well, with fewer than 2% of patients having allergic reactions or suspected transfusion reactions and about 2% of patients having only biochemical hypocalcemia from citrate toxicity.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.
Event or Problem Description
Per journal article "report of the asfa apheresis registry study on focal segmental glomerulosclerosis" by poyyapakkam srivaths, grace f.Monis, leonor p.Fernando, jeanne e.Hendrickson, jay s.Raval, cyril jacquot, keefe davis, edward wong, chisa yamad abstract: focal segmental glomerulosclerosis (fsgs) is one of the causes of end-stage kidney disease.The etiology is not fully understood, and standardized treatments are not established.We created a registry on apheresis for post-transplant fsgs through the renal subcommittee in the research committee in the american society for apheresis (asfa), and here is our first report.Members of the renal subcommittee from seven centers in the united states contributed data collection on demographic, clinical course, and overall outcomes of patients with post-transplant recurrence of fsgs treated with therapeutic plasma exchange (tpe) between 2015 and 2020.The tpe data, including frequency and replacement fluid for tpe, are also investigated.The median age at diagnosis of fsgs and first transplantation among 26 patients was 12.7 and 21 years, respectively.The fsgs recurred at a median of 1 day after transplantation, and tpe was performed daily or every other day in the first month and continued at some frequency beyond a year in some cases.Most procedures used albumin as a replacement fluid and citrate anticoagulation, with 1¿1.5 plasma volumes exchange.Twelve patients had complete/partial remission by 6 months.The median urine protein/creatinine ratio improved from 4.47 to 1.4 mg/mg within 3 months, and egfr improved from 26 to 78 ml/min/1.73 m2 in a year after tpe started.The study revealed some uniformity in the prescription of tpe, primarily using albumin as replacement fluid and performing 1¿1.5 plasma volume exchanges.Observed complication rates were minimal.Tpe can be one of the treatments to consider in this condition.Most patients tolerated tpe well.There were two instances of allergic reactions with plasma replacement, two instances of suspected transfusion reactions, and three instances of asymptomatic hypocalcemia in the first 4 weeks of treatment.Most patients tolerated tpe well, with fewer than 2% of patients having allergic reactions or suspected transfusion reactions and about 2% of patients having only biochemical hypocalcemia from citrate toxicity.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
This report is being filed to provide additional information in h.6 and h.11.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that there is no allegation against a tbct device.No further reporting will be provided as this does not represent a reportable event.Lot number, manufacture date and expiry date are not available at this time.Citation: srivaths, p., monis, g.F., fernando, l.P., hendrickson, j.E., raval, j.S., jacquot, c., davis, k., wong, e., & yamada, c.(2025).Report of the asfa apheresis registry study on focal segmental glomerulosclerosis.Journal of clinical apheresis, 40(4).Https://doi.Org/10.1002/jca.70041.

• 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: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 22885475
• Report Number: 1722028-2025-00194
• Device Sequence Number: 8918725
• Product Code: LKN
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 4122201
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 02/26/2026
• 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