MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTO RBC AND PLASMA SET

Catalog Number 80520

Device Problems High Test Results (2457); Filtration Problem (2941); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2016

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.A red blood cell bag containing product and segmented tubing was returned for investigation.Internal testing is being performed on the returned rbc product to determine the residual wbc count and are awaiting on test results.Investigation is in progress.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 blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.(b)(6).

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.Test results on the returned rbc product indicated the rwbc count was 106.31x10^6.Root cause: a definitive root cause for the observed leuko reduction failure remains undetermined at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the run data file (rdf) was analyzed for this event.Updated root cause: a definitive root cause for the observed leuko reduction failure remains undetermined at this time.The trima accel run data files were analyzed and the signals did not indicate any potential cause for the reported wbc contaminations.No unusual process variables were identified and the signals in the run data file indicate that the trima accel systems operated as intended.It cannot be ruled out that these leukoreduction failures could be the result of an issue with the filters.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTO RBC AND PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5651682
• MDR Text Key: 46284831
• Report Number: 1722028-2016-00296
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Catalogue Number: 80520
• Device Lot Number: 03Z3214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other