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

Catalog Number	10310
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number, manufacture date and expiry date are not available at this time.Investigation: per the customer, this occurred because the port of the saline bag was orange in color, which led to the orange ac spike being connected, and because the experienced operator did not perform a double check. the hospital¿s response was to use saline bags with ports that are not orange in color and to ensure that double checks are always performed.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that the ac spike and the saline spike were mistakenly interchanged during a procedure on spectra optia.The issue was noticed during the procedure and the processing was terminated.The patient experienced numbness due to hypocalcemia at an early stage after the start of collection.The ionized calcium level measured at that time was 1.2 mmol.When the customer contact a tbct representative, he advised that rinseback should not be performed; however, by that time, the saline had already been reconnected to the inlet side manifold and rinseback had been performed.Per the customer, "the symptoms subsequently improved" patient information is unknown at this time.The collection set is not available for return because it was discarded by the customer.

• 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: 24969220
• Report Number: 1722028-2026-00055
• Device Sequence Number: 18765907
• 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
• Report Date (Section B): 04/23/2026

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: 10310
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 06/03/2026; 07/01/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/11/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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