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

Catalog Number	4123201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that after a continuous mononuclear cell collection (cmnc) the patient's hematocrit dropped from 37% to 25% requiring 2 untis of blood.  per customer patient outcome "stable before and after procedure.Discharged." the collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation: per follow up with the customer, the patient received blood because too many rbcs were collected during the procedure.The patient would not have normally needed blood transfusions after the procedure.The equipment was serviced/evaluated and no issues were identified, the equipment passed all tests.   investigation is in process, a follow-up report will be provided.

• Brand Name: Spectra Optia
• Common Device Name: SPECTRA OPTIA IDL 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: 50436013
• Report Number: 1722028-2026-00120
• Device Sequence Number: 10423183
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: 4123201
• Device Lot Number: 2510236141
• 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: 07/31/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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: 17 YR
• Patient Sex: Male
• Patient Weight: 114 LB