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

Model Number 80440

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.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.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.Donor unit #:(b)(6).The 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 e1 and e3.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: a conclusive root cause for the elevated level of wbcs in the platelet product could not be determined.Alerts that could contribute to wbc contamination of the platelet product, such as ¿centrifuge pressure high¿ or ¿rbc spillover¿, were not generated in this run data file.Possible causes include but are not limited to: a high donor wbc count, stopped centrifuge during the procedure, rbc detector calibration error, air block, and/or orientation of the tubing as loaded in the centrifuge hex holder compromised the structural integrity of the plasma tubing and caused a higher flow through the lrs chamber.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9526273
• MDR Text Key: 186735452
• Report Number: 1722028-2019-00446
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80440
• Device Catalogue Number: 80440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/07/2020; 03/09/2020
• Supplement Dates FDA Received: 02/13/2020; 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other