MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC / PLASMA, ISBT

Catalog Number	4825002
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	03/12/2024
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 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.Wbc count is not available at this time.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, h.6 and h.11.Investigation: 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.The lrs chamber has a fixed volume and therefore holds a fixed number of white blood cells for a given chamber flow.On infrequent occasions, this holding capacity may be exceeded, causing higher than expected white blood cell content within the product.This may result in a collected product with greater than expected wbc count.The trima machine may give a message to verify the wbc content in the product or may provide no message to the operator depending on the circumstances.Root cause: there are various reasons for elevated wbc levels in collected product such as donor factors, kit misloads, airblocks, disposable set deviations, paused centrifuge, or other processing difficulty in maintaining the steady state necessary to efficiently separate blood components.Regarding donor factors, there appears to be patterns with repeat donors that produce platelet products with high wbc counts.Saturation events leading to elevated wbcs in collected product are also possible if the donor pre-counts are entered falsely much lower than actual as this can cause the lrs chamber to fill before the system expects and wbcs to escape before detection.Misloading of a set or disposable set deviation may cause a plasma line occlusion or an air block within the centrifuge which may lead to the white blood cells getting flushed out of the lrs chamber into the product.
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.Wbc count is not available from the customer the platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL RBC / PLASMA, ISBT
• 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: 19153701
• Report Number: 1722028-2024-00149
• Device Sequence Number: 8463972
• Product Code: GKT
• UDI-Device Identifier: 05020583825000
• UDI-Public: 05020583825000
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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 Expiration Date: 07/01/2025
• Device Catalogue Number: 4825002
• Device Lot Number: 2307182142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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