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

Catalog Number	4101201
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file and associated aim images did not indicate a conclusive root cause for the reported ¿low-level reservoir sensor detected air¿ alarm.The procedure was generally uneventful with few alarms or other signs (eg.Clumping) that could have contributed to the early termination of the run.The ¿low-level reservoir sensor detected air¿ alarm occurs when the safety system detects air at the lower level reservoir sensor.Possible causes are foamy blood, the centrifuge speed being within a certain range causing the system to vibrate too much, or a defective level sensor.Signals in the dlog suggest that the centrifuge speed was not a likely cause of the alarm.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a mononuclear cell (mnc) procedure a "low-level reservoir sensor detected air¿ alarm occurred and foam was visually detected in the return line.The operator decided to discontinue the procedure.The cd34 collection goals were attained.Patient information is unknown at this time, gender and weight were obtained from the run data file (rdf).Per customer "patient was clinically stable" and no medical intervention was required.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, b.5, b.7, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file and associated aim images did not indicate a conclusive root cause for the reported ¿low-level reservoir sensor detected air¿ alarm.The procedure was generally uneventful with few alarms or other signs (eg.Clumping) that could have contributed to the early termination of the run.The ¿low-level reservoir sensor detected air¿ alarm occurs when the safety system detects air at the lower-level reservoir sensor.Possible causes are foamy blood, the centrifuge speed being within a certain range causing the system to vibrate too much, or a defective level sensor.Signals in the dlog suggest that the centrifuge speed was not a likely cause of the alarm.The customer submitted three photographs in lieu of the disposable set to aid investigation.One photo shows the optia tyvek lid confirming the set details, lot 2310116141, catalog 10120.One photo shows the optia device screen confirming the low-level reservoir sensor alarm.The ac line is noted to be flossed correctly in the ac detector, and the return pump header tubing is loaded in the pump raceway adequately.Foam is observed in the reservoir, air is noted in the rbc recirc line, and what appears to be clumping is noted in the inlet filter.The last photo shows a section of the return and inlet lines and confirms the presence of many small air bubbles in the return line.Two small air bubbles are observed in the ac line.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 a mononuclear cell (mnc) procedure a "low-level reservoir sensor detected air¿ alarm occurred and foam was visually detected in the return line.The operator decided to discontinue the procedure.The cd34 collection goals were attained.Patient id was not provided.Gender and weight were obtained from the run data file (rdf).Per customer "patient was clinically stable" and no medical intervention was required.The therapy is continuing.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that during a mononuclear cell (mnc) procedure a "low-level reservoir sensor detected air¿ alarm occurred and foam was visually detected in the return line.The operator decided to discontinue the procedure.The cd34 collection goals were attained.Patient id was not provided.Gender and weight were obtained from the run data file (rdf).Per customer "patient was clinically stable" and no medical intervention was required.The therapy is continuing.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 h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file and associated aim images did not indicate a conclusive root cause for the reported ¿low-level reservoir sensor detected air¿ alarm.The procedure was generally uneventful with few alarms or other signs (eg.Clumping) that could have contributed to the early termination of the run.The ¿low-level reservoir sensor detected air¿ alarm occurs when the safety system detects air at the lower level reservoir sensor.Possible causes are foamy blood, the centrifuge speed being within a certain range causing the system to vibrate too much, or a defective level sensor.Signals in the dlog suggest that the centrifuge speed was not a likely cause of the alarm.The customer submitted three photographs in lieu of the disposable set to aid investigation.One photo shows the optia tyvek lid confirming the set details, lot 2310116141, catalog 10120.One photo shows the optia device screen confirming the low level reservoir sensor alarm.The ac line is noted to be flossed correctly in the ac detector, and the return pump header tubing is loaded in the pump raceway adequately.Foam is observed in the reservoir, air is noted in the rbc recirc line, and what appears to be clumping is noted in the inlet filter.The last photo shows a section of the return and inlet lines and confirms the presence of many small air bubbles in the return line.Two small air bubbles are observed in the ac line.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found 0 reports for similar issues on this lot.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a mononuclear cell (mnc) procedure a "low-level reservoir sensor detected air¿ alarm occurred and foam was visually detected in the return line.The operator decided to discontinue the procedure.The cd34 collection goals were attained.Patient id was not provided.Gender and weight were obtained from the run data file (rdf).Per customer "patient was clinically stable" and no medical intervention was required.The therapy is continuing.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 d.4, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file and associated aim images did not indicate a conclusive root cause for the reported ¿low-level reservoir sensor detected air¿ alarm.The procedure was generally uneventful with few alarms or other signs (eg.Clumping) that could have contributed to the early termination of the run.The ¿low-level reservoir sensor detected air¿ alarm occurs when the safety system detects air at the lower level reservoir sensor.Possible causes are foamy blood, the centrifuge speed being within a certain range causing the system to vibrate too much, or a defective level sensor.Signals in the dlog suggest that the centrifuge speed was not a likely cause of the alarm.The customer submitted three photographs in lieu of the disposable set to aid investigation.One photo shows the optia tyvek lid confirming the set details, lot 2310116141, catalog 10120.One photo shows the optia device screen confirming the low level reservoir sensor alarm.The ac line is noted to be flossed correctly in the ac detector, and the return pump header tubing is loaded in the pump raceway adequately.Foam is observed in the reservoir, air is noted in the rbc recirc line, and what appears to be clumping is noted in the inlet filter.The last photo shows a section of the return and inlet lines and confirms the presence of many small air bubbles in the return line.Two small air bubbles are observed in the ac line.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found 0 reports for similar issues on this lot.Root cause: review of the run data file and associated aim images did not indicate a conclusive root cause for the reported ¿low-level reservoir sensor detected air¿ alarm.The procedure was generally uneventful with few alarms or other signs (e.G.Clumping) that could have contributed to the early termination of the run.The ¿low-level reservoir sensor detected air¿ alarm occurs when the safety system detects air at the lower-level reservoir sensor.Possible causes are foamy blood, the centrifuge speed being within a certain range causing the system to vibrate too much, or a defective level sensor.Signals in the dlog suggest that the centrifuge speed was not a likely cause of the alarm.The picture provided by the customer seems to suggest that foamy blood was the cause of the alarm.Based on the available information a definitive root cause of the air and foam in the return line and reservoir could not be determined but it is likely due to one or a combination of the possible causes listed below: an occlusion in the disposable set due to manufacturing error, including solvent or molding occlusions a kink or an occlusion in the collect line.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 23367846
• Report Number: 1722028-2025-00231
• Device Sequence Number: 18362670
• Product Code: LKN
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Report Date (Section B): 10/23/2025

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 Expiration Date: 10/01/2025
• Device Catalogue Number: 4101201
• Device Lot Number: 2310116141
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 01/05/2026; 01/22/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/02/2026; 01/21/2026; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 72 KG