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

Catalog Number 82321

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is still 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.(b)(6) 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.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.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.Root cause: a definitive root cause for the observed elevated wbc count remains undetermined at this time.The analysis of the rdf did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.There were no events (alerts, adjustments, changes in pump speed, substate changes, etc.) during the procedure that could have caused wbcs to escape from the lrs chamber.Signals from the rbc detector showed that during the collection the signal was varied with scatter indicating a mixture of cells was exiting the lrs chamber.Although the system has several methods for detection of wbc contaminations, it is possible that this eluded the detection capability of the system.It is also possible that this leukoreduction failure may have been due to improper loading of the tubing set,a tubing set defect or may be donor related.

Event Description

This product is not available within the us, but this report is being filed due to an alleged failurethat could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to correct information in date of event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, + AUTOPAS, PLASMA, SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6300726
• MDR Text Key: 66779994
• Report Number: 1722028-2017-00029
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK150321
• 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: 02/03/2017

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 Expiration Date: 08/01/2018
• Device Catalogue Number: 82321
• Device Lot Number: 08Z9121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/24/2017; 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• 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