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

Model Number	80440
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem Description
Kw 03-30-2021.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,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
This report is being filed to provide additional information in b.6, h.6, and h.10.Investigation: the run data file was analyzed for this event.The platelet count used for the procedure was 275, while the actual donor platelet count was 415.This equated to approximately a 34% difference in actual versus entered platelet count.Hemocue hemoglobin: 13.1 sysmex hemoglobin: 11.9 the customer had used a hemoglobin value (13.1 g/dl) obtained via hemocue (finger stick), which is not as accurate as cbc results (venous blood sample) obtained from a hemotology analyzer.The results from sysmex showed that the actual hemoglobin was 11.9 g/dl.The hematocrit using values from hemocue and sysmex are 39.3 % and 35.7 %, respectively.The inflated hematocrit caused the interface to set up lower in the channel, causing more wbcs to be collected into the rbc line resulted in saturation of the leukoreduction filter.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 occurred during the procedure and likely contributed 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 the factors that cause wbc failures on rbc products include but are not limited to: - 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 the high actual yield can be attributed to the incorrect entry of the donor pre platelet count.Correction: terumo bct field performance communicated to the customer via email that the customer¿s precount process led to precount inaccuracies, which contributed to this failure.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET + SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11385722
• Report Number: 1722028-2021-00086
• Device Sequence Number: 4710954
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• 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): 02/26/2021

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: 05/01/2022
• Device Model Number: 80440
• Device Catalogue Number: 80440
• Device Lot Number: 2005084151
• 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: 02/04/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 06/29/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 05/27/2021; 07/02/2021
• 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