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

Catalog Number 80400

Device Problems Incorrect Or Inadequate Test Results (2456); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number, expiry and manufacture data 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 wbc testing, therefore no patient information is reasonably known at the time of the event.White blood cell (wbc) count is not available at this time.The platelet collection 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 an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.

Event Description

The customer did not respond to multiple attempts to obtain information for the investigation such as initial complainant's first name and lot information.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the run data file (rdf) was analyzed for this event.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: analysis of the run data file showed that platelets did exit the lrs chamber later than expected.Due to the flow adjustments made along the procedure, the flow through the lrs chamber was modified multiple times.It is possible, though not conclusive that wbcs may have exited the lrs chamber throughout the procedure.Based on the available information, it is also possible that this leukoreduction failure is donor related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6630374
• MDR Text Key: 77560578
• Report Number: 1722028-2017-00224
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: BK170059
• 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,Followup,Followup
• Report Date: 06/09/2017

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 Catalogue Number: 80400
• Other Device ID Number: 05020583804005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 07/03/2017; 08/31/2017
• Supplement Dates FDA Received: 07/21/2017; 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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