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

Model Number 80410

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event 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.

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.

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.

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
• Type of Device: TRIMA LRS PLATELET PLASM RBC AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11046216
• MDR Text Key: 223402675
• Report Number: 1722028-2020-00554
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804104
• UDI-Public: 05020583804104
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/28/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 03/01/2021; 06/16/2021; 06/21/2021
• Supplement Dates FDA Received: 03/22/2021; 06/17/2021; 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other