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

Model Number 82446

Device Problems Use of Device Problem (1670); High Readings (2459); Inadequate User Interface (2958)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

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

Manufacturer Narrative

This report is being filed to provide additional information in d.4 and h.4.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h10.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 rdf was examined for this procedure - the precount was changed 7 times at the end of the run.The lrs chamber was saturated just prior to a scheduled purge.Correction: terumo bct field performance communicated to the customer via email on (b)(6) 2021 that the root cause related to a precount inaccuracy.Root cause: based on the information available and run file analysis, the reported issue was due to a precount inaccuracy.The customer uses an average of the last three precounts so sometimes that can be inaccurate enough from the actual venous count on the day of donation to cause a problem.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET + SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11223098
• MDR Text Key: 241832416
• Report Number: 1722028-2021-00023
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824461
• UDI-Public: 05020583824461
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

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: 08/01/2022
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Device Lot Number: 2008144151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 06/07/2021
• Supplement Dates FDA Received: 03/10/2021; 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other