MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS,PLASMA,RBCSET

Catalog Number 82420

Device Problems Use of Device Problem (1670); High Test Results (2457)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used trima disposable containing blood product throughout was received for investigation.Visual inspection confirmed the presence of rbcs within the collect raceway, collect pump header and in the collect bag which had been rf sealed and detached from the disposable by the customer.The plasma bag was not returned with the set.The channel lines and mini-pinch clamps were found to have been assembled correctly and the mini-pinch clamps were returned in the closed position.No damage was noted on the mini-pinch clamps; however, it was noted that the mini-pinch clamp on the plasma line tubing had been closed inadequately and did not appear to be fully occluding the tubing.The mini-pinch clamp on the platelet line appeared to be closed correctly, despite this rbcs were noted past the rbc clamp.Flow testing of platelet line confirmed the mini pinch clamp was fully occluding the tubing.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.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 b.5, h.1, h.6 and h10.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.

Event Description

The customer declined to provide any further details for this event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10 correction: the customer indicated that they did not wish to be contacted in regard to this complaint, therefore re- training could not be performed.Root cause: based on the evaluation of the returned disposable set, the root cause of the rbc contamination in the platelet product was determined to be an improperly closed mini pinch clamp.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER AUTOPAS,PLASMA,RBCSET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10733753
• MDR Text Key: 215985346
• Report Number: 1722028-2020-00484
• 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,Followup
• Report Date: 10/26/2020

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: 02/01/2022
• Device Catalogue Number: 82420
• Device Lot Number: 2002242130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 05/25/2021
• Supplement Dates FDA Received: 11/18/2020; 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other