MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLT, AUTOPAS, PLASMA, SET

Catalog Number 82321

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

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 bloodcell testing, therefore no patient information is reasonably known at the time of the event.(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.

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.The run data file (rdf) was analyzed for this event.Root cause: a definitive root cause for the observed leukoreduction failure remains undetermined at this time.The analysis of the run data file did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.The run was event free, with no adjustments or changes in pump speed made during the procedure that could have caused the onset of the lrs chamber.It is possible that this leukoreduction failure is donor- related.

Manufacturer Narrative

Additional information: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLT, AUTOPAS, 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: 5494847
• MDR Text Key: 40424425
• Report Number: 1722028-2016-00119
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 03/11/2016

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: 11/01/2017
• Device Catalogue Number: 82321
• Device Lot Number: 11Y9108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2016; 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2015
• 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