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

Model Number 80440

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/06/2020

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.There is no patient involved for this event.Sex and weight are not applicable for this event and can not be removed due to a system limitation.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, h.6 and h.10.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.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the pre-donation cbc was analyzed on (b)(6) 2020, the day after the procedure was run (b)(6) 2020.The platelet count used for the procedure was a previous count (or average) and there as approximately a 7% difference in actual versus entered platelet count.The customer provided donor tracking information including donor cbc results to aid in the investigation.The donor cbc confirmed the following: - the donor's wbc is 4.65e3/ul which is within the normal range of 10e3/ul.The donor's platelet count is 429e3/ul which is on the higher end of the normal range.Root cause: based on the available information, the cause of the reported leukoreduction failure was due to a combination of the donor's elevated platelet precount and the more aggressive ramp up of the inlet pump.

• 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: 11078127
• MDR Text Key: 252269552
• Report Number: 1722028-2020-00577
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2020

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: 06/01/2022
• Device Model Number: 80440
• Device Catalogue Number: 80440
• Device Lot Number: 2006135151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 05/07/2021; 06/25/2021
• Supplement Dates FDA Received: 05/10/2021; 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 121