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

Catalog Number	4123201
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1 full email address: (b)(6).Investigation: one used optia idl set was received for investigation.Initial observations noted prime fluid throughout the set and blood up to and including the rbc recirc line.The reservoir was returned full of prime fluid, however no blood was present in the reservoir.Tubing was connected to the inlet line luer via a 3-way valve.The tubing was rf sealed at the end.The customer also attached a custom blood bag attached via tubing and 3-way valve to the return containing prime fluid.The luers were not loose, however they were not fully tightened either.No air bubbles were visible in the inlet and return tubing lines.The channel was full of blood and swirling was noted.The inlet and return saline roller clamps were returned on the correct lines and in the closed positions.The ac bag and drip chamber were not returned and the lines rf sealed.The ac filter was assembled in the correct orientation.The set was flow tested and no occlusions or leaks were observed on the ac line or filter.The set was further examined for any kinks, leaks, missing parts or misassembles and none were noted.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported during priming customized with blood bag for a stem cell collection there was a presence of air in the return line.The alarm prevented continuation, so the set was replaced and there were no further issues noted.Per the customer, there was no injury or medical intervention required for this event and the patient was clinically stable.The patient was not connected at the time of the event.Patient information is unknown at this time.

• 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: verenia oliver ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 25142688
• Report Number: 1722028-2026-00060
• Device Sequence Number: 13113281
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4123201
• Device Lot Number: 2510166141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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 Sex: Unknown