MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ENHANCED PLT PLS RBC AUTORAC SET

Model Number	80360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigations: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content reported in the rbc product for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.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 red blood cell (rbc) product.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).The 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: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause : the analysis of the run data file did not find a conclusive cause for the higher-than- expected wbc content reported in the rbc product for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.The factors that cause failures include but are not limited to: - imperfections in the filter due to manufacturing or handling - inappropriate use (for example application of excessive pressure) - donor-specific wbc populations that are poorly removed.- inaccurate hematocrit entered resulting in saturation of filter with excessive wbcs - improper loading of filter into the filter bracket.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ENHANCED PLT PLS RBC AUTORAC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10010010
• Report Number: 1722028-2020-00189
• Device Sequence Number: 16890737
• Product Code: GKT
• UDI-Device Identifier: 05020583803602
• UDI-Public: 05020583803602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 04/29/2020

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: 12/01/2021
• Device Model Number: 80360
• Device Catalogue Number: 80360
• Device Lot Number: 1912202130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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