MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER PLS RBC AUTO PAS SET

Catalog Number 82420

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670)

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

Event Date 10/16/2020

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.Terumo bct is awaiting return of the disposable set.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.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: based on the image provided by the customer the misassembly was verified.The channel line mini pinch clamp was not fully threaded onto the collect line tubing.Despite the addition of a hemostat, which allowed the operator to continue the procedure, it is evident from the photo that rbcs spilled over into the collect line, potentially contaminating the platelet product with white blood cells.Root cause: a definitive root cause for the suspected leukoreduction failure is related to the inability of the operator to clamp the collect line tubing from the channel due to a clamp failure.The cause of the clamp failure was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.More specifically, the mini pinch clamp was not adequately flossed onto the channel collect line tubing.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER PLS RBC AUTO PAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10823626
• MDR Text Key: 220982965
• Report Number: 1722028-2020-00507
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 82420
• Device Lot Number: 2007241130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other