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

Catalog Number 82310

Device Problems Misassembled (1398); High Readings (2459)

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

Event Date 04/10/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation: photographs were submitted in lieu of the disposable set to aid in the investigation.Analysis of the images revealed a used trima set containing blood.The mini pinch clamp on the yellow plasma line is confirmed improperly assembled on the tubing line.The open end of the clamp is not flossed on the tubing.The mis-assembled clamp does not allow the tubing to be properly assembled.Based on the available evidence in the images provided, the root cause of the reported failure was a manufacturing mis-assembly.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 elevated white blood cell (wbc) content in the platelet product.After pas addition it was noted that the tubing was not correctly routed though the clamp during manufacturing.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 collection set is not available for return because it was discarded by the customer 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 : 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

Correction: terumo bct has implemented a correction for this incident.Manufacturing staff were made aware of this issue and retrained to the appropriate procedures.Root cause: based on the available evidence in the images provided, the root cause of the reported failure was a manufacturing mis-assembly which lead to the potential for residual wbcs to exit the channel and enter the product bag.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11770301
• MDR Text Key: 251932787
• Report Number: 1722028-2021-00168
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• 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: 82310
• Device Lot Number: 2007221130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other