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

Catalog Number	5824102
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	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.No alerts known to contribute to wbc contamination were generated during this procedure.As the trima accel system does not directly count cells entering the platelet product bag, it relies on significant changes in rbc detector reflectance values to indicate lrs chamber saturation and potential wbc presence in the product.In this case, the signal changes were insufficient to trigger a notification, and the system reported the platelet product as leukoreduced.However, further analysis suggests that wbcs may have begun escaping the lrs chamber earlier than the system anticipated, potentially contributing to the elevated wbc content observed in the final product.While the trima accel system incorporates multiple detection mechanisms for wbc contamination, certain events-such as this one-may fall outside its detection capabilities.Based on the available data, the leukoreduction failure may be associated with donor-specific blood characteristics that challenge the system¿s leukoreduction performance.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.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).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.
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.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 d.4, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.No alerts known to contribute to wbc contamination were generated during this procedure.As the trima accel system does not directly count cells entering the platelet product bag, it relies on significant changes in rbc detector reflectance values to indicate lrs chamber saturation and potential wbc presence in the product.In this case, the signal changes were insufficient to trigger a notification, and the system reported the platelet product as leukoreduced.However, further analysis suggests that wbcs may have begun escaping the lrs chamber earlier than the system anticipated, potentially contributing to the elevated wbc content observed in the final product.While the trima accel system incorporates multiple detection mechanisms for wbc contamination, certain events-such as this one-may fall outside its detection capabilities.Based on the available data, the leukoreduction failure may be associated with donor-specific blood characteristics that challenge the system¿s leukoreduction performance.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.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Root cause: a root cause assessment was performed for this complaint.No alerts known to contribute to wbc contamination were generated during this procedure.As the trima accel system does not directly count cells entering the platelet product bag, it relies on significant changes in rbc detector reflectance values to indicate lrs chamber saturation and potential wbc presence in the product.In this case, the signal changes were insufficient to trigger a notification, and the system reported the platelet product as leukoreduced.However, further analysis suggests that wbcs may have begun escaping the lrs chamber earlier than the system anticipated, potentially contributing to the elevated wbc content observed in the final product.While the trima accel system incorporates multiple detection mechanisms for wbc contamination, certain events-such as this one-may fall outside its detection capabilities.Based on the available data, the leukoreduction failure may be associated with donor-specific blood characteristics that challenge the system¿s leukoreduction performance.

• 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: 23180258
• Report Number: 1722028-2025-00219
• Device Sequence Number: 9108624
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 09/30/2025

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: 5824102
• Device Lot Number: 2503255151
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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