MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SMPL AUTOPAS MULTIPLASMA RBC

Model Number	80370
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The rdf does not show any indication of a contamination event.It is not a situation where the signal from the rbc detector was close to or even moving in the direction of flagging this.That and the fact that the donor has contaminated in previous pas runs does point more to a donor-related phenomenon wherein wbcs were trickling out the entire collection, rather than in a saturation event.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 overflow into the platelet concentrate when the additive solution was added.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 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.Root cause: based on the investigational findings the root cause for the elevated rwbc count is believed to be a donor-related phenomenon wherein wbcs were trickling out the entire collection, rather than in a saturation event.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT SMPL AUTOPAS MULTIPLASMA RBC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10125037
• Report Number: 1722028-2020-00278
• Device Sequence Number: 3791865
• Product Code: GKT
• UDI-Device Identifier: 05020583803701
• UDI-Public: 05020583803701
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/05/2020

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: 12/01/2021
• Device Model Number: 80370
• Device Catalogue Number: 80370
• Device Lot Number: 1912021230
• 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: 05/14/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 03/02/2021
• 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