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

Catalog Number	80360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 run data file (rdf) was analyzed for this event.Root cause: the analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content in the platelet product reported for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.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.
Event or Problem Description
The customer requested the run data file be investigated to determine a possible cause for the higher-than-expected white blood cell (wbc) content in the platelet product.Donor unit id: (b)(4).There was not a transfusion recipient or patient involved at the time of this incident, therefore, no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL LRS PLATELET, SAMPLER, PLASMA, AUTORBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8409213
• Report Number: 1722028-2019-00056
• Device Sequence Number: 10860062
• Product Code: GKT
• UDI-Device Identifier: 05020583803602
• UDI-Public: 05020583803602
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: BK180231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

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: 11/01/2020
• Device Catalogue Number: 80360
• Device Lot Number: 1811202230
• 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: 02/26/2019
• Initial Report FDA Received Date: 03/11/2019
• 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