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

Catalog Number	4824102
Medical Device Problem Codes	Defective Component (2292); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
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 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 residual wbc testing, 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.5, e.3, h.6 and h.11.In lieu of the disposable kit, the customer provided an image to aid the investigation.The returned image captured the product bags hanging on the iv pole of the trima device.The reported incident could be confirmed, red cells were evident in the platelet bag.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 tbct service technician checked out the machine at the customer and confirmed that the rbc detector was out of calibration.The rbc detector was cleaned and recalibrated and auto-tests passed.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 residual wbc testing, therefore no patient information is reasonably known at the time of the event.No patient received the product and no tests of the product were made as it was contaminated with red cells and, therefore, immediately discarded.The actual rwbc count cannot be determined.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 d4, h6 and h11.Investigation: in lieu of the disposable kit, the customer provided an image to aid the investigation.The returned image captured the product bags hanging on the iv pole of the trima device.The reported incident could be confirmed, red cells were evident in the platelet bag.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 tbct service technician checked out the machine at the customer and confirmed that the rbc detector was out of calibration.The rbc detector was cleaned and recalibrated and auto-tests passed.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to a hardware issue.The rbc detector was out of calibration which resulted in the device inability to appropriately flag for a spillover event.
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 residual wbc testing, therefore no patient information is reasonably known at the time of the event.No patient received the product and no tests of the product were made as it was contaminated with red cells and, therefore, immediately discarded.The actual rwbc count cannot be determined.The platelet collection is not available for return because it was discarded by the customer.

• 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: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 23976579
• Report Number: 1722028-2026-00008
• Device Sequence Number: 19974865
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2026

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: 4824102
• Device Lot Number: 2507026442
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/25/2026; 03/20/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/12/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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