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

Model Number	82440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem 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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h6 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 trima accel procedure summary (taps) report was submitted to aid in the investigation.The report confirms there were no flags indicating that the platelet product should be verified for white blood cell contamination.The donor pre platelet count was entered as 545.This donor had an actual precount of 611 on the day of donation.Trima is validated up to donor precount of 575 with maximum entry of 600.Root cause: based on the clinical findings, the cause of the white cell contamination is due to the donor platelet precount being above trima's limit.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLATELET SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10507851
• Report Number: 1722028-2020-00429
• Device Sequence Number: 11080254
• Product Code: GKT
• UDI-Device Identifier: 05020583824409
• UDI-Public: 05020583824409
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: 82440
• Device Catalogue Number: 82440
• Device Lot Number: 2003184151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other