MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLATELET PLASM RBC AUTOPAS SET

Model Number	80410
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	11/27/2020
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.The platelet collection set is not available for return because it was discarded by the customer.The wbc count is not available, at this time.
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.Investigation is in process.A follow up report will be provided.
Additional Manufacturer Narrative
Investigation: per the customer the product was not qc tested and no elevated wbc count was alleged.The customer submitted a photograph showing a used primary platelet bag hung from a trima device.The photograph confirms the presence of a rbc spillover in the platelet bag.The run data file (rdf) was analyzed for this event.Root cause: the trima accel device has software algorithms that use the rbc detector output to monitor and flag if an rbc spillover occurs during pas addition.Run data file analysis confirmed these algorithms were monitoring at all times during the pas addition process, however the reported rbcs were not detected and therefore no alerts were triggered.Run data file analysis did not show any rbc contamination at the rbc detector during the automatic pas addition process.Review of signals at the rbc detector during the automatic pas addition process showed that the cassette was cleaned correctly, and the pas fluid added to the platelet product bag(s) appeared clear.The root cause for the reported rbc contamination during the automatic pas addition process could not be determined from the dlog analysis.Possible causes for rbcs entering the platelet product bag during pas addition include, but are not limited to: ineffective cassette cleaning during the pas priming process where the system cannot identify a change in the signal to detect passing rbcs.Platelet and/or plasma channel line clamps may not have been fully occluding the channel lines, allowing fluid from the channel containing rbcs to be pulled up into the platelet product bags.Inadequate pas fluid connection, causing any rbc contents within the cassette to enter the platelet product bags.Incorrectly primed filter on the pas line.Pas bag frangible not broken correctly or reseated yellow clamp on the pas line not opened fully.
Additional Manufacturer Narrative
This report is being filed to provide additional information in e.3 and corrected information in e.1.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA LRS PLATELET PLASM RBC AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11046216
• Report Number: 1722028-2020-00554
• Device Sequence Number: 19893812
• 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): Y
• 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): 12/21/2020

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: 03/01/2022
• Device Model Number: 80410
• Device Catalogue Number: 80410
• Device Lot Number: 2003042130
• 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: 11/28/2020
• Supplement Date Received by Manufacturer: 03/01/2021; 06/16/2021; 06/21/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 03/22/2021; 06/17/2021; 06/30/2021
• 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