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	Insufficient Information (4580)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that after a therapeutic plasma exchange (tpe) procedure the patient reqiured a platelet transfusion due to a drop in platelet count.  per customer patient status "the patient's condition is unchanged, they are critical icu level care." the collection set is not available for return because it was discarded by the customer.
Event or Problem Description
Customer reported that after a therapeutic plasma exchange (tpe) procedure the patient reqiured a platelet transfusion due to a drop in platelet count.  per customer patient status "the patient's condition is unchanged, they are critical icu level care." 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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.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: 50503148
• Report Number: 1722028-2026-00122
• Device Sequence Number: 9404850
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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
• Device Lot Number: 2604273241
• 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: 08/05/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2026
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 154 LB