MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT,PLASMA,ISBT

Catalog Number	80300
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number, manufacture date and expiry date are not available at this time.Investigation: the machine was checked out at the customer site.A functional test was successfully performed.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.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 wbc count is not available at this time.Per the customer, it was only a user related issue.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.Lot number, manufacture date and expiry date are not available at this time.Investigation: the machine was checked out at the customer site.A functional test was successfully performed.The run data file (rdf) was analyzed for this event.Analysis of the run data files showed that the trima accel device detected wbcs escaping from the lrs chamber.The trima accel has software algorithms in place that use the rbc output to monitor and flag if a potential wbc saturation of the lrs chamber occurred, possibly triggering if wbc cells exiting the lrs chamber and potentially contaminated the platelet product.The message to verify wbcs in the platelet product was displayed because during the procedure these algorithms on the trima accel device operated as intended and detected wbcs were escaping from the lrs chamber.Experience has shown that lrs chamber saturations 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.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 wbc count is not available at this time.Per the customer, it was only a user related issue.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.Lot number, manufacture date and expiry date are not available at this time.Investigation: the machine was checked out at the customer site.A functional test was successfully performed.The run data file (rdf) was analyzed for this event.Analysis of the run data files showed that the trima accel device detected wbcs escaping from the lrs chamber.The trima accel has software algorithms in place that use the rbc output to monitor and flag if a potential wbc saturation of the lrs chamber occurred, possibly triggering if wbc cells exiting the lrs chamber and potentially contaminated the platelet product.The message to verify wbcs in the platelet product was displayed because during the procedure these algorithms on the trima accel device operated as intended and detected wbcs were escaping from the lrs chamber.Experience has shown that lrs chamber saturations may be donor related.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Signals in the run data file (rdf) indicated that the trima device operated as intended by flagging the procedure to verify wbcs.No further reporting will be provided as this does not represent a reportable event.
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.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 wbc count is not available at this time.Per the customer, it was only a user related issue.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLT,PLASMA,ISBT
• 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: 23256325
• Report Number: 1722028-2025-00226
• Device Sequence Number: 13365617
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• 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): 10/09/2025

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: 80300
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 03/10/2026; 03/25/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 03/19/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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