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

Catalog Number 82406

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); High Readings (2459)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2019

Event Type  malfunction  

Manufacturer Narrative

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 would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the red blood cell (rbc) product.There was not a transfusion recipient or patient involved at the time of the residual white bloodcell (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.

Manufacturer Narrative

Correction: retraining of the customer was performed by a terumo bct clinical specialist in october.It was discussed with the customer that all products obtained with catalog 82406 should be filtered in order to reduce the amount of wbcs in the product.Root cause: based on the available information, the cause of the leukoreduction failure in the rbc product was a process issue in which the products were being measured for residual white cells prior to filtration.The 82406 tubing sets do not have in-line filters built in and trima does not guarantee leukoreduction of the rbc product when there is no in-line filter to capture the wbcs.

Manufacturer Narrative

This report is being filed to provide additional information in e.3.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: further evaluation of this event has determined that the device did not causeor contribute to a death or serious injury, nor is there a likely potential for death or serious injuryassociated with this event based on additional investigational information.This procedure was notintended to leukoreduce the rbc concentrate.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide updated information in g1 and g2.Investigation is in process.A follow up report will be provided.

• 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: 8784752
• MDR Text Key: 151001119
• Report Number: 1722028-2019-00180
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824065
• UDI-Public: 05020583824065
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2019

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: 11/01/2020
• Device Catalogue Number: 82406
• Device Lot Number: 1811123130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 08/05/2019; 08/29/2019; 09/23/2019; 12/04/2019
• Supplement Dates FDA Received: 08/06/2019; 08/30/2019; 10/18/2019; 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other