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

Model Number	80410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/10/2020
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 overflow into the platelet concentrate when the additive solution was added.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.Wbc count is not available at this time.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 run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the reported rbcs entering the platelet product during automatic pas addition.The trima system is designed to monitor for an rbc spillover at the rbc detector throughout automatic pas addition to the platelet product.To do this, the system takes a baseline reading at the rbc detector just prior to adding pas to the platelet product bag then monitors for changes from this baseline.Analysis showed that changes from the baseline did not occur during this procedure and therefore, the system did not notify the operator of the rbcs in the line.It is possible, though not conclusive, the platelet and/or plasma channel line clamps may not have been fully occluding the channel lines allowing fluid from the channel containing rbcs and/or wbcs to be pulled up into the platelet product bags.It¿s also possible, though not conclusive, the cassette may not have been fully cleaned during the pas priming phase due to inadequate pas fluid connection, causing the rbc contents within the cassette to enter the platelet product bags.Possible causes for inadequate pas fluid connection include, but are not limited to: an incorrectly primed filter on the pas line, the bag frangible not broken correctly, or the yellow clamp on the pas line not opened fully.The system verifications for adequate clamp closure and pas connection passed without errors, however, some events may elude the detection capability of the system.A photograph was sumbitted in lieu of the disposable to aid in the investigation.Analysis of the photo confirms red cell contamination in the platelet bag.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in e.1.And e.3.After the multiple attempts the customer did not provide an exact job title for the reporter.Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.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.Root cause: run data file analysis did not show a conclusive root cause for the reported rbcs entering the platelet product during automatic pas addition.The trima system is designed to monitor for an rbc spillover at the rbc detector throughout automatic pas addition to the platelet product.To do this, the system takes a baseline reading at the rbc detector just prior to adding pas to the platelet product bag then monitors for changes from this baseline.Analysis showed that changes from the baseline did not occur during this procedure and therefore, the system did not notify the operator of the rbcs in the line.It is possible, though not conclusive, the platelet and/or plasma channel line clamps may not have been fully occluding the channel lines allowing fluid from the channel containing rbcs and/or wbcs to be pulled up into the platelet product bags.It¿s also possible, though not conclusive, the cassette may not have been fully cleaned during the pas priming phase due to inadequate pas fluid connection, causing the rbc contents within the cassette to enter the platelet product bags.Possible causes for inadequate pas fluid connection include, but are not limited to: an incorrectly primed filter on the pas line, the bag frangible not broken correctly, or the yellow clamp on the pas line not opened fully.The system verifications for adequate clamp closure and pas connection passed without errors, however, some events may elude the detection capability of the system.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET AUTO PAS, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10494579
• Report Number: 1722028-2020-00426
• Device Sequence Number: 2199117
• Product Code: GKT
• UDI-Device Identifier: 05020583804104
• UDI-Public: 05020583804104
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup,Followup
• Report Date (Section B): 09/04/2020

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: 01/01/2022
• Device Model Number: 80410
• Device Catalogue Number: 80410
• Device Lot Number: 2001202130
• 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: 08/11/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 02/04/2021; 02/26/2021
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/22/2020; 02/11/2021; 03/05/2021
• 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