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

Catalog Number	4103101
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Wheal(s) (2241); Urticaria (2278)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer stated that during a collection, the patient developed itching approximately one hour after the start of the procedure, and wheals appeared about two hours after start.As a result, the procedure was discontinued.Patient information and outcome are unknown at this time.The customer reported medical intervention but it is unknown what was required.Terumo bct is awaiting return of the collection set for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in a2, a3a, a4, b5, b6, b7, h6 and h11.The run data file (rdf) was analyzed for this event.There were no signals to indicate the device contributed to the adverse patient reactions reported.No definitive root cause for the reported adverse patient reactions could be identified from the dlog associated with this procedure.Per the customer, as g-csf was administered as daily filgrastim rather than pegfilgrastim (g-csf), the possibility that the symptoms were influenced by the g-csf administered on that day cannot be excluded.Overall, the customer believes the evidence is considered insufficient to definitively attribute the event to an eog allergy.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer stated that during a collection, the patient developed itching approximately one hour after the start of the procedure, and wheals appeared about two hours after start.As a result, the procedure was discontinued.Following administration of solu-cortef and polaramine, the skin rash gradually improved.Thereafter, no additional anti-allergic agents were administered, and no recurrence was observed.Patient id is not available at this time.Terumo bct is awaiting return of the collection set for evaluation.
Event or Problem Description
The customer stated that during a collection, the patient developed itching approximately one hour after the start of the procedure, and wheals appeared about two hours after start.As a result, the procedure was discontinued.Following administration of solu-cortef and polaramine, the skin rash gradually improved.Thereafter, no additional anti-allergic agents were administered, and no recurrence was observed.Patient id is not available at this time.Terumo bct is awaiting return of the collection set for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in g.1, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.There were no signals to indicate the device contributed to the adverse patient reactions reported.No definitive root cause for the reported adverse patient reactions could be identified from the dlog associated with this procedure.Per the customer, as g-csf was administered as daily filgrastim rather than pegfilgrastim (g-csf), the possibility that the symptoms were influenced by the g-csf administered on that day cannot be excluded.Overall, the customer believes the evidence is considered insufficient to definitively attribute the event to an eog allergy.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 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: 24769233
• Report Number: 1722028-2026-00051
• Device Sequence Number: 13336984
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/02/2026

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: 4103101
• Device Lot Number: 2508256241
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 04/28/2026; 06/02/2026; 07/01/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/27/2026; 05/21/2026; 06/15/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2025
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 72 KG