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

Model Number 82446

Device Problems Device Ingredient or Reagent Problem (2910); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbc from the lrs chamber during the latter portion of the platelet collection.Based on the available information, it cannot be ruled out that the higher-than- expected wbc content in the platelet product could be donor-related due to high wbc count.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

Investigation : a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The donor's complete blood count (cbc) results and donation history were provided to aid in the investigation.The donor cbc confirmed the following: the donor's wbc is 14.79e3/ul which is above the normal range of 10e3/ul.The donor's platelet count is 528e3/ul which is above the normal range.The information provided suggests the donor platelet count entered into the trima was 472 x 10^3/ul, while the lab count from the donor's cbc was 528 x 10 ^3/ul.This discrepancy in actual value verses entered value could have contributed to the leukoreduction failure.It should be noted that a similar discrepancy occurred with the donor's previous donation.The entered count was 441 x 10^3/ul and the actual count was 520 x 10^3/ul.This collection did not result in a leukoreduction failure.Root cause : the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbc from the lrs chamber during the latter portion of the platelet collection.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor- related due to high wbc count, high platelet count, and/or the discrepancy in entered versus actual platelet count.

• 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: 10508242
• MDR Text Key: 206188643
• Report Number: 1722028-2020-00434
• 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
• Report Date: 09/09/2020

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: 07/01/2022
• Device Model Number: 82446
• Device Catalogue Number: 82446
• Device Lot Number: 2007201230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other