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

Model Number	80406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
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, however it is possible that the higher-than-expected wbc content was the result of an escape of wbcs from the lrs chamber during a portion of the procedure.The signals indicate that the device had difficulty 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.Additionally, 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.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: there was no conclusive root cause identified for the higher-than-expected wbc content in the platelet product reported for this procedure, however it is possible that the higher-than-expected wbc content was the result of an escape of wbcs from the lrs chamber during a portion of the procedure.The signals indicate that the device had difficulty 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.Additionally, 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.
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.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLATELET, PLASMA, RBC 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: 17165166
• Report Number: 1722028-2023-00215
• Device Sequence Number: 5818367
• Product Code: GKT
• UDI-Device Identifier: 05020583804067
• UDI-Public: 05020583804067
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 06/20/2023

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: 01/01/2025
• Device Model Number: 80406
• Device Catalogue Number: 4824062
• Device Lot Number: 2301052142
• 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: 05/31/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2023
• 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
• Patient Sex: Unknown