MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTORBC, PLASMA SET

Catalog Number	4825202
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	08/30/2023
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.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 is in process, a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima accel system cannot count the cells entering the platelet bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima accel system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima accel system.It is also possible that this leukoreduction failure is donor related.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 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.Donor unit #: (b)(6) 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 investigation: the run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima accel system cannot count the cells entering the platelet bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima accel system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima accel system.It is also possible that this leukoreduction failure is donor related.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima accel system cannot count the cells entering the platelet bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima accel system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima accel system.It is also possible that this leukoreduction failure is donor related.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.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.During customer follow-up, it was confirmed that the wbc count was below ¿¿¿5x10^6 per transfusable unit.Root cause: run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Alerts that are known to contribute to wbc contamination were not generated in this run data file.As the trima accel system cannot count the cells entering the platelet bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima accel system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima accel system.It is also possible that this leukoreduction failure is donor related.No further reporting will be provided as this does not represent a reportable event.
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.Donor unit #: (b)(6) 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 AUTORBC, PLASMA 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: 17818374
• Report Number: 1722028-2023-00319
• Device Sequence Number: 6138076
• Product Code: GKT
• UDI-Device Identifier: 05020583825208
• UDI-Public: 05020583825208
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/26/2023

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: 03/01/2025
• Device Catalogue Number: 4825202
• Device Lot Number: 2303271142
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 11/20/2023; 01/03/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/13/2023; 12/05/2023; 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2023
• 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