MAUDE Adverse Event Report: TERUMO BCT, INC. Spectra Optia®; Separator, Automated, Blood Cell And Plasma, Therapeutic

Model Number	61000
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Treatment started at 1300.At 1335 fluid leak detector alarmed indicating fluid in centrifuge area.Treatment paused, centrifuge door opened and noted blood leak.Treatment was terminated with ebl "[estimated blood loss]" 185ml.All component of kit were double checked prior to treatment.Upon inspection all components were properly loaded into the machine.Breakage was noted in tubing distal to hexagon lock.Manufacturer was notified of kit malfunction, and information sent per their request.Optia removed from service for deep cleaning and inspection by htm "[healthcare technology management]"/vendor.

• Brand Name: Spectra Optia®
• Common Device Name: Separator, Automated, Blood Cell And Plasma, Therapeutic
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 w collins ave; lakewood CO 80215
• MDR Report Key: 50461860
• Report Number: 50461860
• Device Sequence Number: 10241160
• Product Code: LKN
• UDI-Device Identifier: 05020583610002
• UDI-Public: (01)05020583610002
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/19/2026
• Report Date (Section F): 08/19/2026

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
• Device Model Number: 61000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 08/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 08/19/2026