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

Catalog Number	12220
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a therapeutic plasma exchange (tpe) procedure on an optia device the system alarmed continued to detect cells in plasma line and had "orange plasma".The operator checked the green line was attached to 0.9% normal saline, orange line was attached to acd-a, replacement spikes were attached to the fresh frozen plasma.The physician wanted the procedure aborted and couldn't give a reason for the "orange plasma." there was no medical intervention.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Lot number and manufacture date are not available at this time.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a therapeutic plasma exchange (tpe) procedure on an optia device the system alarmed continued to detect cells in plasma line and had "orange plasma".The operator checked the green line was attached to 0.9% normal saline, orange line was attached to acd-a, replacement spikes were attached to the fresh frozen plasma.The physician wanted the procedure aborted and couldn't give a reason for the "orange plasma." there was no medical intervention.Patient information and outcome are unknown at this time.Sex and weight were obtained from the rdf.The collection 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 a.3a, a.4, b.6, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event. review of the run data file shows there was a total of 7 occurrences between the alarms ¿cells were detected in plasma line from centrifuge¿ & ¿system continued to detect cells in plasma line from centrifuge¿.In tpe, the system generates these alarms when the rbc detector signals indicate a value greater than 1.5, indicating a darker than expected plasma was detected in the plasma line.The alarm may occur for various reasons including small air bubble(s) at the rbc detector, the entered patient hematocrit was too low leading to a high interface and spill over, or a shift in the patient fluid balance caused the actual patient hematocrit to increase leading to a spill over, or possible hemolysis or elevated bilirubin.In response to this alarm, it is suggested to increase the patient hct by 3% points for up to 9% points.In this procedure, the operator initially decreased the patient hct from 29% to 23% before increasing it to 36% by 6 minutes into the procedure.Aim images reviewed for this procedure show a developed cell interface that was maintained around the middle of the channel connector during this procedure.There was no clear evidence of clumping during the run but there was some possible buffy coat accumulation identified.Signals in the run data file do not show the occurrence of any aim alarms indicating a higher-than-expected interface during the procedure.Review of the aim images do not point to a clear root cause for the occurrence of these alarms.Analysis of the run data file cannot confirm the occurrence of hemolysis during this procedure.No clear root cause could be determined for the slightly darker than expected plasma reported during this procedure.If hemolysis is suspected, follow your sop for proper testing and confirmation of hemolysis.The device was found to be operating as intended with the appropriate alarms raised and all safety systems remaining in place.  lot number and manufacture date are not available at this time.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: verenia oliver ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 24767601
• Report Number: 1722028-2026-00050
• Device Sequence Number: 10276194
• Product Code: LKN
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 12220
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 05/21/2026; 05/27/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/27/2026; 05/21/2026; 06/09/2026
• 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: Female
• Patient Weight: 67 KG