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	07/12/2024
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 higher-than-expected wbc content in the platelet product was possibly the result of a wbc saturation of the lrs chamber toward the end of the procedure.Based on the signals in the run data file, it cannot be ruled out that the donor's platelets may have been activating in the channel and in the lrs chamber, disrupting the packed bed and causing platelets to exit the centrifuge in an inconsistent manner.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.Additionally, the signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during portions of the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.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 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.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly the result of a wbc saturation of the lrs chamber toward the end of the procedure.Based on the signals in the run data file, it cannot be ruled out that the donor's platelets may have been activating in the channel and in the lrs chamber, disrupting the packed bed and causing platelets to exit the centrifuge in an inconsistent manner.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.Additionally, the signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during portions of the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.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: for this donor's future donations, you may consider proactively making two 'system ac up' adjustments to increase the anticoagulant in the system as soon as the option becomes available.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.In order to efficiently collect platelets, the trima accel system needs to operate at steady state.Please refer to the trima accel screens, operator's manual, and your sops for information on minimizing donor access issues.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly the result of a wbc saturation of the lrs chamber toward the end of the procedure.Based on the signals in the run data file, it cannot be ruled out that the donor's platelets may have been activating in the channel and in the lrs chamber, disrupting the packed bed and causing platelets to exit the centrifuge in an inconsistent manner.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been donor-related.Additionally, the signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during portions of the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.
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: 19940034
• Report Number: 1722028-2024-00327
• Device Sequence Number: 14690814
• Product Code: GKT
• UDI-Device Identifier: 05020583826168
• UDI-Public: 05020583826168
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/08/2024

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: 12/01/2025
• Device Catalogue Number: 4826162
• Device Lot Number: 2312211142
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2023
• 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