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 Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
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.Citation: fjellbirkeland, o.W., szpirt, w.M., & børresen, m.L.(2023).The role of plasmapheresis in severe acute disseminated encephalomyelitis with clinical findings of transverse myelitis.Therapeutic apheresis and dialysis, 28(1), 119¿124.Https://doi.Org/10.1111/1744-9987.14059.
Event or Problem Description
Per journal article "the role of plasmapheresis in severe acute disseminated encephalomyelitis with clinical findings of transverse myelitis.Therapeutic apheresis and dialysis" by fjellbirkeland, o.W., szpirt, w.M., & børresen, m.L.Three liters of plasma were removed (58 ml plasma/kg weight) and replaced with a replacement fluid consisting of 20% human albumin and ringer's acetate (ratio 1:4) using the spectra optia system.Each exchange procedure was completed within 90 min.The first two sessions were performed daily followed by three every other day.Immediately following the first procedure, the patient experienced moderate hypotension (blood pressure 89/49).No further complications following the remaining procedures were observed.The patient received hdmp for an additional 3 days, followed by 7 days of 75 mg oral prednisolone.Per journal article "a month after discharge, the patient was still recovering.She had regained normal motor function but suffered from fatigue, poor concentration, and headaches.An mri was performed 5 weeks after the index attack and demonstrated complete resolution of the abnormalities.During 3 months, the dose of prednisone was gradually reduced.At the three-month follow-up, the patient was able to return to school and perform daily tasks.However, she had intermittent back pain and urgency urinary incontinence which resolved within the next year." the collection set is not available for return because it was discarded by the customer.Specific details, such as patient id and weight were not included in the article for these events, therefore this report is being provided as a summary of the event.It is unknown at this time if medical intervention was required.
Event or Problem Description
Per journal article "the role of plasmapheresis in severe acute disseminated encephalomyelitis with clinical findings of transverse myelitis.Therapeutic apheresis and dialysis" by fjellbirkeland, o.W., szpirt, w.M., & børresen, m.L.Three liters of plasma were removed (58 ml plasma/kg weight) and replaced with a replacement fluid consisting of 20% human albumin and ringer's acetate (ratio 1:4) using the spectra optia system.Each exchange procedure was completed within 90 min.The first two sessions were performed daily followed by three every other day.Immediately following the first procedure, the patient experienced moderate hypotension (blood pressure 89/49).No further complications following the remaining procedures were observed.The patient received hdmp for an additional 3 days, followed by 7 days of 75 mg oral prednisolone.Per journal article "a month after discharge, the patient was still recovering.She had regained normal motor function but suffered from fatigue, poor concentration, and headaches.An mri was performed 5 weeks after the index attack and demonstrated complete resolution of the abnormalities.During 3 months, the dose of prednisone was gradually reduced.At the three-month follow-up, the patient was able to return to school and perform daily tasks.However, she had intermittent back pain and urgency urinary incontinence which resolved within the next year." the collection set is not available for return because it was discarded by the customer.Specific details, such as patient id and weight were not included in the article for these events, therefore this report is being provided as a summary of the event.It is unknown at this time if medical intervention was required.
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 was no allegation of medical intervention for the adverse events.No further reporting will be provided as this does not represent a reportable event.Citation: fjellbirkeland, o.W., szpirt, w.M., & børresen, m.L.(2023).The role of plasmapheresis in severe acute disseminated encephalomyelitis with clinical findings of transverse myelitis.Therapeutic apheresis and dialysis, 28(1), 119¿124.Https://doi.Org/10.1111/1744-9987.14059.

• 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: 23632043
• Report Number: 1722028-2025-00254
• Device Sequence Number: 18525811
• Product Code: LKN
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/05/2026
• 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 Age: 16 YR
• Patient Sex: Female