MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PPC, SAMPLER, PLASMA, RBC SET

Catalog Number 80491

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and evaluation.The run data file(rdf) was analyzed for this event.Root cause: the rdf analysis did not show a conclusive root cause for the reported elevated wbc content in the collected platelet product.Signals from the run data file showed that platelets exited shortly after the platelet valve opened and continued consistently throughout the procedure.There were no events during the procedure (adjustments, changes in pump speed, substate changes, etc.) that corresponds with potential overloading of the lrs chamber.Based on the available information; it is possible that this leukoreduction failure may be donor related.

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 bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit# (b)(6).The disposable kit 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 a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PPC, SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 5175566
• MDR Text Key: 29851058
• Report Number: 1722028-2015-00596
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/30/2015

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: 08/01/2017
• Device Catalogue Number: 80491
• Device Lot Number: 08Y9105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• 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