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	04/21/2025
Type of Reportable Event	Malfunction
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) per the customer, the unit was filtered and then transfused.There was not adverse event reported from the transfused unit.Recipient information is unknown at this time.The platelet collection set is not available for return because it was discarded by the customer.
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) per the customer, the unit was filtered and then transfused.There was not adverse event reported from the transfused unit.Recipient information is unknown at this time.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.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)(4)per the customer, 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 a.1, b.5, b.6, 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.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.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Based on the available information, it is possible, though not conclusive, this failure may be donor related.It is also possible, though not conclusive, entry of a lower than actual donor platelet precount may have contributed to the elevated wbc content in the platelet product reported for this collection.By system design, when rinseback is not performed, there is no check for proper closure of the channel line clamps and the system assumes they were closed as prompted.As such, it cannot be ruled out that the channel line clamps were left open during the automatic pas addition process, leading to possible wbc contamination being pulled up from the channel.While the trima accel system is typically robust against numerous access pressure pauses, it is possible, though not conclusive, the alerts throughout this procedure may have disrupted the steady state of the system and contributed to the higher-than-expected wbc content in the platelet product.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.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.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Based on the available information, it is possible, though not conclusive, this failure may be donor related.It is also possible, though not conclusive, entry of a lower than actual donor platelet precount may have contributed to the elevated wbc content in the platelet product reported for this collection.By system design, when rinseback is not performed, there is no check for proper closure of the channel line clamps and the system assumes they were closed as prompted.As such, it cannot be ruled out that the channel line clamps were left open during the automatic pas addition process, leading to possible wbc contamination being pulled up from the channel.While the trima accel system is typically robust against numerous access pressure pauses, it is possible, though not conclusive, the alerts throughout this procedure may have disrupted the steady state of the system and contributed to the higher-than-expected wbc content in the platelet product.

• 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: 22044971
• Report Number: 1722028-2025-00129
• Device Sequence Number: 21052890
• 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): 05/19/2025

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: 2411282142
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/31/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/07/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2024
• 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