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

Model Number	80440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time 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.No patient is involved, patient sex and weight are not applicable for this event and can not be removed due to a system limitation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.6, h.6 and h.10.Investigation: 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 11.64e3/ul which is above the normal range of 10e3/ul.- the donor's platelet count is 374e3/ul which is elevated.- the donor¿s mean platelet volume (mpv)is 10.7 fl which is within normal range the customer reported that this donor has two previous donations on record and both also have elevated prewbc counts (11.48 [10^3/microl] and 13.21 [10^3/microl]).Per the clinical specialist, the customer did not provide the lot number.Additionally, it was determined this failure was donor related.As such, a dhr search of the batch number is not required.Root cause: based on the findings of the clinical specialist, the cause of the residual white cell contamination was the donor's physiology.Specifically, the donor's elevated pre-procedure white blood cell count.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET, SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11077916
• Report Number: 1722028-2020-00575
• Device Sequence Number: 14462349
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 80440
• Device Catalogue Number: 80440
• 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: 12/07/2020
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 05/10/2021
• 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
• Patient Weight: 137