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

Catalog Number 80355

Device Problems Low Test Results (2458); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number, expiry and manufacture date 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 white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(4).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 in corrected information is provided in investigation: the device history records (dhr) were reviewed for this lot.There were noevents noted in the dhr that would have contributed to the elevated wbc count experiencedby the customer.The run data file (rdf) was analyzed for this event.Root cause: a definitive root cause for the observed leukoreduction failure remainsundetermined at this time.The run data file analysis did not show a conclusive root cause for the higher- than-expected wbccontent in the platelet product reported for this collection.Analysis of the rbc detector signalshowed that platelets took longer than expected to initially exit the lrs chamber.This meansthat there was a delay between when the trima accel device predicted that platelets werecollecting and when they actually started collecting platelets in the bag.However, it is possible,though not conclusive, that some wbcs may have been escaping the lrs chamber along with theplatelets during the collection.Based on the available information, it is possible that thisleukoreduction failure may be donor related.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET PLASMA AUTO RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8680206
• MDR Text Key: 147628240
• Report Number: 1722028-2019-00139
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

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: 10/01/2019
• Device Catalogue Number: 80355
• Device Lot Number: 1710042330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other