MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS 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	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the machine was checked out at the customer site.The rbc calibrator was cleaned and calibrated.A successful autotest was performed.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 overflow into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The platelet collection 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 overflow into the platelet concentrate when the additive solution was added.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The platelet collection 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, e.1, g.1, h.6 and h.11.Investigation: the machine was checked out at the customer site.The rbc calibrator was cleaned and calibrated.A successful autotest was performed.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.In lieu of the disposable set, the customer supplied multiple images to aid the investigation.The returned images relate to this record and the linked record in the associated reference objects section.Of the 4 images, 6 platelet bags are captured, two of which are tinged pink, confirming a spillover event.The run data file (rdf) was analyzed for this event.After pas connection, the run data file indicates that the cassette was properly cleaned and the reservoir filled to the upper level sensor, confirming adequate pas flow.Pas was also detected in from of the rbc detector at the start of the pas addition phase.Shortly after pas addition began, a slight divergence between the red and green rbc signals was observed.Although this divergence did not exceed the threshold to trigger an alert, it may suggest insufficient pas flow.Trima accel device has software algorithms that use the rbc detector output to monitor and flag if an rbc spillover during platelet additive solution addition occurred.At all times during the platelet additive solution addition phase the test was in place, however, the level of detector of rbcs passing the rbc detector did not trigger an alert.Analysis of the run data file did not show a conclusive root cause for the reported rbc spillover during platelet additive solution addition.Root cause: a root cause assessment was performed for this complaint.After pas connection, the run data file indicates that the cassette was properly cleaned and the reservoir filled to the upper level sensor, confirming adequate pas flow.Pas was also detected in from of the rbc detector at the start of the pas addition phase.Shortly after pas addition began, a slight divergence between the red and green rbc signals was observed.Although this divergence did not exceed the threshold to trigger an alert, it may suggest insufficient pas flow.Trima accel device has software algorithms that use the rbc detector output to monitor and flag if an rbc spillover during platelet additive solution addition occurred.At all times during the platelet additive solution addition phase the test was in place, however, the level of detector of rbcs passing the rbc detector did not trigger an alert.Analysis of the run data file did not show a conclusive root cause for the reported rbc spillover during platelet additive solution addition.Possible causes for rbcs entering the platelet product bag during pas addition include, but are not limited to:- ineffective cassette cleaning during the pas priming process where the system cannot identify a change in the signal to detect passing rbcs- platelet and/or plasma channel line clamps may not have been fully occluding the channel lines, allowing fluid from the channel containing rbcs to be pulled up into the platelet product bags- inadequate pas fluid connection, causing any rbc contents within the cassette to enter the platelet product bags- incorrectly primed filter on the pas line- pas bag frangible not broken correctly or reseated- yellow clamp on the pas line not opened fully.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA LRS 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: verenia oliver ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 23944551
• Report Number: 1722028-2026-00001
• Device Sequence Number: 21522186
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/02/2026

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: 12/09/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2025
• 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