MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET AUTO PAS, PLASMA SET

Catalog Number 82321

Device Problems High Readings (2459); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2020

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 blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).The platelet collection set 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 in b.6, h.6 and h.10.Investigation: 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.Signals in the run data file (rdf) indicated that the trima device operated as intended by flagging the procedure to verify wbcs.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: analysis of the run data file show that the trima accel device detected wbcs escaping from the lrs chamber at approximately 73 minutes into the procedure.The trima accel device has software algorithms in place that use the rbc output to monitor and flag if a potential wbc saturation of the lrs chamber occurred, possibly triggering if wbc cells exiting the lrs chamber and potentially contaminated the platelet product.The system message to verify the wbcs in the platelet product was displayed because during the procedure these algorithms on the trima accel device operated as intended and detected wbcs were escaping from the lrs chamber.A donor related phenomenon cannot be ruled out, as experience has shown that lrs chamber saturations may be donor related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET AUTO PAS, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10741975
• MDR Text Key: 215985160
• Report Number: 1722028-2020-00486
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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: 04/01/2022
• Device Catalogue Number: 82321
• Device Lot Number: 2004242130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other