MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SMPLR AUTOPAS, MULTI PLS, RBC

Catalog Number	4824602
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	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.It was also noted that there were no signs of clumping or clotting in the set.Hemostats, tubing strippers, and water pressurized via syringe were used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All witness and wear marks indicate individual loop and channel components were properly loaded.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 red blood contamination during pas addition.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 terumo bct is awaiting return of the disposable set for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.6, h.6 and h.11.Investigation: a used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.It was also noted that there were no signs of clumping or clotting in the set.Hemostats, tubing strippers, and water pressurized via syringe were used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All witness and wear marks indicate individual loop and channel components were properly loaded.The run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the pumped volumes were all within the expected ranges, and that all checks were passed during additive solution addition.Based on the available information, it cannot be ruled out that the clamp which was left partially open may have resulted in rbcs being pulled from the channel and into the platelet product bags.Additionally, it cannot be ruled out that the cassette may not have been completely cleaned of rbcs prior to the platelet valve opening to add pas to the product bags.The signals in the run data file indicate that the green reflectance value did not drop below the minimum threshold, nor did the ratio of the red to green reflectance exceed the maximum threshold, for flagging the platelet product for wbc verification during pas addition.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 red blood contamination during pas addition.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.It was also noted that there were no signs of clumping or clotting in the set.Hemostats, tubing strippers, and water pressurized via syringe were used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All witness and wear marks indicate individual loop and channel components were properly loaded.The run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the pumped volumes were all within the expected ranges, and that all checks were passed during additive solution addition.Based on the available information, it cannot be ruled out that the clamp which was left partially open may have resulted in rbcs being pulled from the channel and into the platelet product bags.Additionally, it cannot be ruled out that the cassette may not have been completely cleaned of rbcs prior to the platelet valve opening to add pas to the product bags.The signals in the run data file indicate that the green reflectance value did not drop below the minimum threshold, nor did the ratio of the red to green reflectance exceed the maximum threshold, for flagging the platelet product for wbc verification during pas addition.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.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 red blood contamination during pas addition.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.11.Investigation: a used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.It was also noted that there were no signs of clumping or clotting in the set.Hemostats, tubing strippers, and water pressurized via syringe were used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All witness and wear marks indicate individual loop and channel components were properly loaded.The run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the pumped volumes were all within the expected ranges, and that all checks were passed during additive solution addition.Based on the available information, it cannot be ruled out that the clamp which was left partially open may have resulted in rbcs being pulled from the channel and into the platelet product bags.Additionally, it cannot be ruled out that the cassette may not have been completely cleaned of rbcs prior to the platelet valve opening to add pas to the product bags.The signals in the run data file indicate that the green reflectance value did not drop below the minimum threshold, nor did the ratio of the red to green reflectance exceed the maximum threshold, for flagging the platelet product for wbc verification during pas addition.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for this complaint.The signals in the run data file indicate that the pumped volumes were all within the expected ranges, and that all checks were passed during additive solution addition.Based on the available information, it cannot be ruled out that the clamp which was left partially open may have resulted in rbcs being pulled from the channel and into the platelet product bags.Additionally, it cannot be ruled out that the cassette may not have been completely cleaned of rbcs prior to the platelet valve opening to add pas to the product bags.The signals in the run data file indicate that the green reflectance value did not drop below the minimum threshold, nor did the ratio of the red to green reflectance exceed the maximum threshold, for flagging the platelet product for wbc verification during pas addition.
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 double platelet product (double).There was red blood contamination during pas addition.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.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT SMPLR AUTOPAS, MULTI PLS, RBC
• 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: 22507938
• Report Number: 1722028-2025-00158
• Device Sequence Number: 9264901
• Product Code: GKT
• UDI-Device Identifier: 05020583824065
• UDI-Public: 05020583824065
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/15/2025

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 Expiration Date: 10/01/2026
• Device Catalogue Number: 4824602
• Device Lot Number: 2410181142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 12/16/2025; 01/09/2026
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/08/2025; 12/29/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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