MAUDE Adverse Event Report: Terumo BCT Spectra Optia; SPECTRA OPTIA IDL SET

Catalog Number	4123201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported during the red blood cell depletion of allogeneic bone marrow, an incident occurred involving the optia kit required to perform this type of processing.Specifically, the machine displayed the error message "overpressure at the ring", and a leak was observed by the operator.The patient was given prophylactic antibiotic therapy.Due to eu personal data protection laws, the patient information is not available from the customer. .
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.One used optia idl set was received for investigation.Initial observations noted blood throughout the set and the reservoir was approx.30 % full.Further inspection of the loop noted that there were witness marks on the upper bearing and the ears were adequately snapped into place with no damage on the ears, however there was minimal damage to the bottom of the upper bearing where it looked to have been slightly sheared.Further observations noted blood on the exterior of the braid towards the lower portion of the braid, adjacent to the lower bearing.The ears of the lower bearing were snapped in place; however, the ears did appear sheared.When manipulating the lower bearing, there was white debris under the bearing, and damage.Inspection of the lower bearing did show a witness mark.Further inspection of the sleeve noted a severe crack in the middle, exposing the underlying four lumen.Inspection of the four-lumen noted that the rbc and inlet lines were sheared, identifying the leak pathway and confirming the customers complaint.No other missing leak, missing parts or missasembles were noted.  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: kristi edgington ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 50254978
• Report Number: 1722028-2026-00117
• Device Sequence Number: 10070774
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: 4123201
• Device Lot Number: 2601283141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2026
• 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