MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA SET

Model Number	80400
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	06/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.No patient (donor) was connected at the time of the event, therefore, no patient information is known.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.No patient (donor) was connected at the time of the event, therefore, no patient information is known.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 b.6, h.6 and h.10.Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The run data file (rdf) was analyzed for this event.Root cause: run data file analysis did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.Alerts that could contribute to wbc contamination of the platelet product, such as ¿centrifuge pressure high¿ or ¿rbc spillover¿, were not generated in this run data file.As the rbc detector cannot count the cells passing by, in order to generate a ¿potential wbc contamination detected¿ message, the rbc detector signals must see a significant change in the reflectance values.In this case, rbc detector reflectance 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.It is possible, though not conclusive, that this leukoreduction failure may be donor related.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL RBC PLT/PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 12093511
• Report Number: 1722028-2021-00227
• Device Sequence Number: 1521516
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 06/30/2021

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 Model Number: 80400
• Device Catalogue Number: 80400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other