MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT +35ML SAMPLER, MULTIPLS, RBC

Model Number	82416
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	04/13/2020
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.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 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 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.The trima accel procedure summary (taps) report was submitted to aid in the investigation.There were no alerts or adjustments throughout the procedure.The report confirms there were no flags indicating that the platelet product should be verified for white blood cell contamination.Root cause: although the system has several methods for detection of wbc contaminations, some events may elude the detection capability of the trima accel system.The following events can occur during the procedure and may contribute to elevated wbc content in the platelet product that the system cannot always detect.A majority of the time, these events will not contribute to elevated wbc content: multiple alerts or flow adjustments that stop/slow the pumps, disrupting the steady-state collection process.Large discrepancy in entered versus actual donor information.Plasma line occlusion or air block that was not large enough to be detected by the system.If the configured platelet concentration during collection is above approximately 3500e3/ul, it is possible that an inaccurate platelet yield scaling factor (ysf) configuration can cause the platelet concentration to exceed the lrs chamber holding capacity due to collecting a higher than expected platelet yield additionally, it is possible that the cause is related to donor specific blood characteristics that may challenge the trima leukoreduction system, including, but not limited to: a higher donor bmi, a donor pre-wbc count that is above the trima accel system expectation, larger than average donor platelet size, and/or smaller than average donor wbc or rbc size.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT +35ML SAMPLER, MULTIPLS, RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10043290
• Report Number: 1722028-2020-00230
• Device Sequence Number: 2916478
• Product Code: GKT
• UDI-Device Identifier: 05020583824164
• UDI-Public: 05020583824164
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 05/11/2020

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: 02/01/2022
• Device Model Number: 82416
• Device Catalogue Number: 82416
• Device Lot Number: 2002131230
• 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: 04/17/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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