MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMALRS 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	06/06/2025
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 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 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 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.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 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.The customer submitted photographs of a pas line during pas addition of a trima procedure.Visual inspection confirmed the presence of severe kinks on the pas filter outlet tubing in multiple locations.The run data file (rdf) was analyzed for this event.Run data file analysis showed a ¿pas prime error¿ alert was raised in this procedure.Following the system prompt to connect pas, the system verifies that pas was properly connected and flowing as expected.This is confirmed by pumping pas into the empty reservoir using the platelet and plasma pumps.Once the lower reservoir sensor detects pas fluid, it will run the return pump.If the return pump cannot run for an adequate amount of volume due to air being detected at the lower reservoir sensor, the ¿pas prime error¿ alert will be raised indicating that the lower reservoir sensor does not consistently detect the presence of pas in the reservoir.The ¿pas prime error¿ alerts in this procedure were generated because pas was not consistently detected at the lower reservoir sensor when expected.Run data file analysis did not show a conclusive root cause for the repeated ¿pas prime error¿ alerts.Possible causes for these alerts include, but are not limited to: small air bubbles may have been stuck over the lower reservoir sensor causing it to read air when fluid was present frangible on the pas bag (if present) may not have been properly broken.The pas filter may have not been completely wetted before the pumps started running.The yellow clamp on the pas line may have been closed.Occlusion in the pas line, such as the y-connector 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 platelet collection set 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 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.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 b.5, b.6, d.4, 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 customer submitted photographs of a pas line during pas addition of a trima procedure.Visual inspection confirmed the presence of severe kinks on the pas filter outlet tubing in multiple locations.The run data file (rdf) was analyzed for this event.Run data file analysis showed a ¿pas prime error¿ alert was raised in this procedure.Following the system prompt to connect pas, the system verifies that pas was properly connected and flowing as expected.This is confirmed by pumping pas into the empty reservoir using the platelet and plasma pumps.Once the lower reservoir sensor detects pas fluid, it will run the return pump.If the return pump cannot run for an adequate amount of volume due to air being detected at the lower reservoir sensor, the ¿pas prime error¿ alert will be raised indicating that the lower reservoir sensor does not consistently detect the presence of pas in the reservoir.The ¿pas prime error¿ alerts in this procedure were generated because pas was not consistently detected at the lower reservoir sensor when expected.Run data file analysis did not show a conclusive root cause for the repeated ¿pas prime error¿ alerts.Possible causes for these alerts include, but are not limited to: - small air bubbles may have been stuck over the lower reservoir sensor causing it to read air when fluid was present - frangible on the pas bag (if present) may not have been properly broken - the pas filter may not have been completely wetted before the pumps started running - the yellow clamp on the pas line may have been closed - occlusion in the pas line, such as the y-connector a disposable complaint history search was performed for this lot and found 1 other report for a similar issue on this lot.See mdr: 1722028-2025-00159 root cause: a root cause assessment was performed for this complaint.Run data file analysis showed a ¿pas prime error¿ alert was raised in this procedure.Following the system prompt to connect pas, the system verifies that pas was properly connected and flowing as expected.This is confirmed by pumping pas into the empty reservoir using the platelet and plasma pumps.Once the lower reservoir sensor detects pas fluid, it will run the return pump.If the return pump cannot run for an adequate amount of volume due to air being detected at the lower reservoir sensor, the ¿pas prime error¿ alert will be raised indicating that the lower reservoir sensor does not consistently detect the presence of pas in the reservoir.The ¿pas prime error¿ alerts in this procedure were generated because pas was not consistently detected at the lower reservoir sensor when expected.Run data file analysis did not show a conclusive root cause for the repeated ¿pas prime error¿ alerts.Possible causes for these alerts include, but are not limited to: - small air bubbles may have been stuck over the lower reservoir sensor causing it to read air when fluid was present - frangible on the pas bag (if present) may not have been properly broken - the pas filter may not have been completely wetted before the pumps started running - the yellow clamp on the pas line may have been closed.

• 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: 22530722
• Report Number: 1722028-2025-00161
• Device Sequence Number: 20704967
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/17/2025

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: 5824102
• Device Lot Number: 2412215151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 09/09/2025; 10/07/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/11/2025; 09/29/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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