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

Catalog Number	4122201
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that after a sickle cell patient underwent a red cell exchange procedure their platelet count decreased by 97 percent (the expected drop range is 30-50 percent).Prior to the procedure the patient's platelet count was 229 x 10^9/l as on (b)(6) 2025, but after the procedure on (b)(6) 2025 their platelet count was 7 x 10^9/l.The patient then returned the following night on (b)(6) 2025) for a platelet check which showed a platelet count of 80 x 10^9/l.Per the apheresis nursing team's assessment of the situation nothing abnormal had occurred.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
This report is being filed to provide additional information in d.4, 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.The run data file (rdf) was analyzed for this event.A conclusive root cause for the reported higher than expected platelet loss for this procedure could not be identified.In rbcx, as rbcs are continuously pushed out of the connector to the remove bag during the procedure, other components are also removed with the rbc¿s including the platelets that have settled into the buffy coat.Refer to the ¿exchange procedure warnings¿ in the optia operator¿s manual, where an approximate percentage of 63% platelets can be removed for one tbv processed.In this case there were 1.1 tbv¿s of patient blood volume processed.From analysis of the run data files there is no clear root cause suggesting why the platelet depletion was greater than expected this procedure.The run data files and associated aim images show the system was performing as intended, with the appropriate alarms raised and no issues identified.A disposable complaint history search was performed for this lot and found zero further reports for a similar issue on this lot.According to the therapeutic apheresis: a physician¿s handbook, the rate of adverse events during therapeutic apheresis is 4% to 5%, with the risk being slightly higher during the first procedure, and varying considerably with the type of procedure.According to the therapeutic apheresis: a physician¿s handbook; as large volumes of donor or patient blood circulate through an apheresis device, blood cells are intentionally or incidentally removed.The effects of single apheresis procedures have been studied extensively, especially in the setting of platelet donation.The thrust of these studies is that individual apheresis procedures produce only modest decreases in circulating blood cell counts, which are not associated with any immediate side effects.With some early apheresis equipment, significant platelet loss was reported during plasma exchange.With current centrifugal technology, reductions in platelet count are usually modest, and levels quickly return to baseline.In a severely thrombocytopenic patient, however, such a loss may mask the beginning of platelet recovery.Root cause: a conclusive root cause for the reported higher than expected platelet loss for this procedure could not be identified.In rbcx, as rbcs are continuously pushed out of the connector to the remove bag during the procedure, other components are also removed with the rbc¿s including the platelets that have settled into the buffy coat.Refer to the ¿exchange procedure warnings¿ in the optia operator¿s manual, where an approximate percentage of 63% platelets can be removed for one tbv processed.In this case there were 1.1 tbv¿s of patient blood volume processed.From analysis of the run data files there is no clear root cause suggesting why the platelet depletion was greater than expected this procedure.The run data files and associated aim images show the system was performing as intended, with the appropriate alarms raised and no issues identified.The system remains safe to use.Based on the available information, a definitive root cause cannot be determined, the platelet count significantly improved the following day, therefore it is possible that there were sampling differences between the two days as the count rebounded very quickly, however this cannot be definitively determined.It is currently unknown if the line was flushed, where the samples were collected from, if the samples were re-tested after returning such a low result, or if there were any sampling errors.
Event or Problem Description
The customer reported that after a sickle cell patient underwent a red cell exchange procedure their platelet count decreased by 97 percent (the expected drop range is 30-50 percent).Prior to the procedure the patient's platelet count was 229 x 10^9/l as of (b)(6) 2025, but after the procedure on (b)(6) 2025 their platelet count was 7 x 10^9/l.The patient then returned the following night ((b)(6) 2025) for a platelet check which showed a platelet count of 80 x 10^9/l.Per the apheresis nursing team's assessment of the situation nothing abnormal had occurred.Patient information and outcome are unknown at this time.Patient gender and weight were obtained from the run data file.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.5, b.6, 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.The run data file (rdf) was analyzed for this event.A conclusive root cause for the reported higher than expected platelet loss for this procedure could not be identified.In rbcx, as rbcs are continuously pushed out of the connector to the remove bag during the procedure, other components are also removed with the rbc¿s including the platelets that have settled into the buffy coat.Refer to the ¿exchange procedure warnings¿ in the optia operator¿s manual, where an approximate percentage of 63% platelets can be removed for one tbv processed.In this case there were 1.1 tbv¿s of patient blood volume processed.From analysis of the run data files there is no clear root cause suggesting why the platelet depletion was greater than expected this procedure.The run data files and associated aim images show the system was performing as intended, with the appropriate alarms raised and no issues identified.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that after a sickle cell patient underwent a red cell exchange procedure their platelet count decreased by 97 percent (the expected drop range is 30-50 percent).Prior to the procedure the patient's platelet count was 229 x 10^9/l as of (b)(6) 2025, but after the procedure on (b)(6) 2025 their platelet count was 7 x 10^9/l.The patient then returned the following night (b)(6) 2025 for a platelet check which showed a platelet count of 80 x 10^9/l.Per the apheresis nursing team's assessment of the situation nothing abnormal had occurred.Patient information and outcome are unknown at this time.Patient sex and weight were obtained from the run data file.The collection set is not available for return because it was discarded by the customer.

• 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: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 23415833
• Report Number: 1722028-2025-00235
• Device Sequence Number: 10407844
• Product Code: LKN
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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 Catalogue Number: 4122201
• Device Lot Number: 2504246341
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 01/09/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/06/2026; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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: Other
• Patient Sex: Male
• Patient Weight: 77 KG