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 Codes	Anemia (1706); Insufficient Information (4580)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during an exchange procedure on a pediatric patient the red saline roller clamp popped off the line and blood backed up into the saline bag.The ecmo team then told the apheresis operator it had popped off during connecting the line to the ecmo circuit.The ending fluid balance was reported as 100%.The customer reported a blood transfusion due to a drop in hematocrit.The patent was reported as having evans syndrome and unstable in the intensive care unit.Patient was connected to ecmo and crrt.The patient was given calcium gluconate 2,400 mg iv given throughout the procedure.The exchange set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that during an exchange procedure on a pediatric patient the red saline roller clamp popped off the line and blood backed up into the saline bag.The ecmo team then told the apheresis operator it had popped off during connecting the line to the ecmo circuit.The ending fluid balance was reported as 100%.The customer reported a blood transfusion due to a drop in hematocrit.The patent was reported as having evans syndrome and unstable in the intensive care unit.Patient was connected to ecmo and crrt.The patient was given calcium gluconate 2,400 mg iv given throughout the procedure.The exchange set is not available for return because it was discarded by the customer.
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 unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during an exchange procedure on a pediatric patient the red saline roller clamp popped off the line and blood backed up into the saline bag.The ecmo team then told the apheresis operator it had popped off during connecting the line to the ecmo circuit.The ending fluid balance was reported as 100%.The customer reported a blood transfusion due to a drop in hematocrit.The patent was reported as having evans syndrome and unstable in the intensive care unit.Patient was connected to ecmo and crrt.The patient was given calcium gluconate 2,400 mg iv given throughout the procedure.The exchange set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in g.1,  h.6 and h.11.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: this specific incident was escalated to the relevant manufacturing personnel for awareness.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: 23842568
• Report Number: 1722028-2025-00278
• Device Sequence Number: 15942072
• Product Code: LKN
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 12/18/2025

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: 2503263141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 02/24/2026; 02/24/2026; 07/28/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/26/2026; 05/07/2026; 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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: Required Intervention
• Patient Age: 13 MO
• Patient Sex: Female
• Patient Weight: 26 LB