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

Catalog Number	4826162
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	05/01/2024
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 id #: (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.There was no conclusive root cause identified for the higher-than-expected wbc content in the platelet product reported for this procedure.The signals in the run data file indicate that at 37 minutes into procedure 8, a 8.9e11 platelet yield collection at a concentration of 1586 x1000/¿l, the operator changed the procedure selection to procedure 9, a 7.4e11 platelet yield collection at a concentration of 1285 x1000/¿l.The signals show that there was a disruption in the steady state flow of platelets exiting the lrs chamber shortly after the operator made this change to the procedure selection.Based on the available information, it cannot be ruled out that the change in procedure selection at 37 minutes into the run may have contributed to the higher-than-expected wbc content in the platelet product.Additionally, based on the available information, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been 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.Donor unit id #: (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
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.There was no conclusive root cause identified for the higher-than-expected wbc content in the platelet product reported for this procedure.The signals in the run data file indicate that at 37 minutes into procedure 8, a 8.9e11 platelet yield collection at a concentration of 1586 x1000/l, the operator changed the procedure selection to procedure 9, a 7.4e11 platelet yield collection at a concentration of 1285 x1000/l.The signals show that there was a disruption in the steady state flow of platelets exiting the lrs chamber shortly after the operator made this change to the procedure selection.Based on the available information, it cannot be ruled out that the change in procedure selection at 37 minutes into the run may have contributed to the higher-than-expected wbc content in the platelet product.Additionally, based on the available information, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been 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.
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.There was no conclusive root cause identified for the higher-than-expected wbc content in the platelet product reported for this procedure.The signals in the run data file indicate that at 37 minutes into procedure 8, a 8.9e11 platelet yield collection at a concentration of 1586 x1000/l, the operator changed the procedure selection to procedure 9, a 7.4e11 platelet yield collection at a concentration of 1285 x1000/l.The signals show that there was a disruption in the steady state flow of platelets exiting the lrs chamber shortly after the operator made this change to the procedure selection.Based on the available information, it cannot be ruled out that the change in procedure selection at 37 minutes into the run may have contributed to the higher-than-expected wbc content in the platelet product.Additionally, based on the available information, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been 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.Correction: you may consider making changes to the procedure selection as early into the procedure as possible.Selecting a different procedure later into the run may result in non-optimal collections.In order to effectively separate blood components, the trima accel system relies on an accurate donor platelet pre-count.Because of this, care should be taken to ensure that the entered platelet pre-count is as accurate as possible.Please see the trima accel operator's manual for donor platelet pre-count best practices.You may also consider monitoring this donor's next few platelet donations for wbcs to determine if there is any donor specific leukoreduction failure trend.Root cause: there was no conclusive root cause identified for the higher-than-expected wbc content in the platelet product reported for this procedure.The signals in the run data file indicate that at 37 minutes into procedure 8, a 8.9e11 platelet yield collection at a concentration of 1586 x1000/l, the operator changed the procedure selection to procedure 9, a 7.4e11 platelet yield collection at a concentration of 1285 x1000/l.The signals show that there was a disruption in the steady state flow of platelets exiting the lrs chamber shortly after the operator made this change to the procedure selection.Based on the available information, it cannot be ruled out that the change in procedure selection at 37 minutes into the run may have contributed to the higher-than-expected wbc content in the platelet product.Additionally, based on the available information, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.
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 id #: (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.

• 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: 19406477
• Report Number: 1722028-2024-00191
• Device Sequence Number: 6955352
• Product Code: GKT
• UDI-Device Identifier: 05020583826168
• UDI-Public: 05020583826168
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 05/28/2024

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: 11/01/2025
• Device Catalogue Number: 4826162
• Device Lot Number: 2311021142
• 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: 05/04/2024
• Supplement Date Received by Manufacturer: 06/26/2024; 07/18/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/15/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• 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