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

Model Number	80520
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	02/08/2021
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 a 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)(4).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 h6 and h10.Investigation: 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: evaluation of the corresponding procedure record and taps report indicated the first rbc product as 364 ml with 100 ml of additive solution and the second rbc product as 363 ml with 100 ml additive solution.Both rbc products could be labeled as leukoreduced with no product verification messages shown.Root cause: the analysis of the run data file did not find a conclusive cause for the higher-than- expected wbc content reported in rbc unit 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 ACCEL AUTO RBC, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11425668
• Report Number: 1722028-2021-00093
• Device Sequence Number: 3430926
• Product Code: GKT
• UDI-Device Identifier: 05020583805200
• UDI-Public: 05020583805200
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/05/2021

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 Expiration Date: 08/01/2022
• Device Model Number: 80520
• Device Catalogue Number: 80520
• Device Lot Number: 2008112130
• 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: 02/10/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 08/04/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 06/24/2021; 08/05/2021
• 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