MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT + SAMPLER, PLASMA, AUTOR

Catalog Number	4826162
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	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the trima accel system, and in particular the rbc detector, operated as intended.The signals indicate that the presence of rbcs in the plasma and platelet bags may have been the result of an rbc spillover which occurred from 12 to 17 minutes into the procedure, and which fell just under the detection threshold for automatically initiating a spillover recovery.Based on the available information, it cannot be ruled out that this rbc spillover may have been the result of a misload of the disposable channel and tubing in the centrifuge, or may have been the result of a misassembly of the specific tubing set used for this procedure.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 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 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 run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the trima accel system, and in particular the rbc detector, operated as intended.The signals indicate that the presence of rbcs in the plasma and platelet bags may have been the result of an rbc spillover which occurred from 12 to 17 minutes into the procedure, and which fell just under the detection threshold for automatically initiating a spillover recovery.Based on the available information, it cannot be ruled out that this rbc spillover may have been the result of a misload of the disposable channel and tubing in the centrifuge, or may have been the result of a misassembly of the specific tubing set used for this procedure.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.It was confirmed that there was no allegation of an elevated white cell count, and the rdf confirmed the device alarmed for an rbc spillover.No further reporting will be provided as this does not represent a reportable event.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT + SAMPLER, PLASMA, AUTOR
• 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: 21035563
• Report Number: 1722028-2024-00575
• Device Sequence Number: 8539280
• Product Code: GKT
• UDI-Device Identifier: 05020583826168
• UDI-Public: 05020583826168
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: 4826162
• Device Lot Number: 2407021142
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• 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