MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMALRS PLATELET PLASMA RBC AUTOPAS SET

Catalog Number	4824102
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	10/11/2025
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 would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.Donor unit #: (b)(6) the wbc count is not available at this time there was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The platelet 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 device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Analysis showed the platelet product collection was terminated early by the operator following ¿return pressure too high¿ alerts.When the operator terminated collection, they did not do rinseback but still completed automatic pas addition.A ¿verify wbc content in the platelet product due to rinseback not completed¿ end of run summary message will only present for pas addition procedures if rinseback was started, but not completed or if a rbc product was collecting at the time the collection was terminated.This is because the lines leading to the platelet product bag should already be leukoreduced when platelet product collection is actively occurring at the time collection is terminated without rinseback.Alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima system cannot count the cells entering the platelet product bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima system.Based on the available information, it is possible, though not conclusive, this failure may be donor related.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.Donor unit #: (b)(6) the wbc count is not available at this time there was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The platelet 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 b.6, d.4, h.6 and h.11.Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Analysis showed the platelet product collection was terminated early by the operator following ¿return pressure too high¿ alerts.When the operator terminated collection, they did not do rinseback but still completed automatic pas addition.A ¿verify wbc content in the platelet product due to rinseback not completed¿ end of run summary message will only present for pas addition procedures if rinseback was started, but not completed or if a rbc product was collecting at the time the collection was terminated.This is because the lines leading to the platelet product bag should already be leukoreduced when platelet product collection is actively occurring at the time collection is terminated without rinseback.Alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima system cannot count the cells entering the platelet product bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima system.Based on the available information, it is possible, though not conclusive, this failure may be donor related.Root cause: a root cause assessment was performed for this complaint.In relation to the elevated rwbc, run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Analysis showed the platelet product collection was terminated early by the operator following ¿return pressure too high¿ alerts.When the operator terminated collection, they did not do rinseback but still completed automatic pas addition.A ¿verify wbc content in the platelet product due to rinseback not completed¿ end of run summary message will only present for pas addition procedures if rinseback was started, but not completed or if a rbc product was collecting at the time the collection was terminated.This is because the lines leading to the platelet product bag should already be leukoreduced when platelet product collection is actively occurring at the time collection is terminated without rinseback.Alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima system cannot count the cells entering the platelet product bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima system.Based on the available information, it is possible, though not conclusive, this failure may be donor related.In relation to the product leakage, based on the information provided, the root cause of the reported leak could not be determined.Possible causes include but are not limited to:* handling at the customer site* post collection/storage/transport.
Event or Problem Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.Donor unit #: (b)(6) there was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.There was no impact on the donor or patient because the unit was filtered before transfusion.The unit had fewer than 1x10^6 leukocytes/unit after the filtration, there was no reaction as a leakage was reported before the transfusion.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMALRS PLATELET PLASMA RBC AUTOPAS 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: 23584470
• Report Number: 1722028-2025-00250
• Device Sequence Number: 13172018
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: BK190332
• 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): 11/18/2025

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: 4824102
• Device Lot Number: 2503286142
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 01/29/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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: Unknown