MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT, PLS, AUTO RBC SET

Catalog Number	4826562
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	09/06/2023
Type of Reportable Event	Malfunction
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.Donor unit #: (b)(6) 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
Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not identify a conclusive root cause for the higher-than-expected wbc content in the platelet product reported for this collection, however it is possible that the higher-than-expected wbc content was the result of an escape of wbcs from the lrs chamber during portions of the procedure.The signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, it cannot be ruled out that the donor's platelets may have been activating in the channel and not consistently exiting the centrifuge into the collect bag.This donor-related platelet behavior may have contributed to the wbc contamination of the product.Investigation is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not identify a conclusive root cause for the higher-than-expected wbc content in the platelet product reported for this collection, however it is possible that the higher-than-expected wbc content was the result of an escape of wbcs from the lrs chamber during portions of the procedure.The signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, it cannot be ruled out that the donor's platelets may have been activating in the channel and not consistently exiting the centrifuge into the collect bag.This donor-related platelet behavior may have contributed to the wbc contamination of the product.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.Donor unit #: (b)(6).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.Donor unit #: (b)(4) 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
Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not identify a conclusive root cause for the higher-than-expected wbc content in the platelet product reported for this collection, however it is possible that the higher-than-expected wbc content was the result of an escape of wbcs from the lrs chamber during portions of the procedure.The signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, it cannot be ruled out that the donor's platelets may have been activating in the channel and not consistently exiting the centrifuge into the collect bag.This donor-related platelet behavior may have contributed to the wbc contamination of the product.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.Root cause: the analysis of the run data file did not identify a conclusive root cause for the higher-than-expected wbc content in the platelet product reported for this collection, however it is possible that the higher-than expected wbc content was the result of an escape of wbcs from the lrs chamber during portions of the procedure.The signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, it cannot be ruled out that the donor's platelets may have been activating in the channel and not consistently exiting the centrifuge into the collect bag.This donor-related platelet behavior may have contributed to the wbc contamination of the product.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLT, PLS, AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood 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: 17851838
• Report Number: 1722028-2023-00327
• Device Sequence Number: 16982368
• Product Code: GKT
• UDI-Device Identifier: 05020583826564
• UDI-Public: 05020583826564
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 10/02/2023

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: 11/01/2024
• Device Catalogue Number: 4826562
• Device Lot Number: 2211081142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 11/10/2023; 11/27/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/20/2023; 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2022
• 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