MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA

Model Number	80400
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
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 reported that during a donation procedure, a donor experienced loss of consciousness (loc).The loc lasted approximately 90 seconds and the donor was not recovering after an hour, so the md on call had the staff call ems to transport to the ed for hydration.The donor was released from the ed after one bag of iv fluids.Patient (donor) information is not available at this time.The disposable 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 h10.Investigation : the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.According to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.Investigation is in process.A follow up report will be provided.
Event or Problem Description
The customer stated that they are unable to provide donor (patient) information.
Additional Manufacturer Narrative
Root cause: a definitive root cause for the reported adverse events could not be determined.Possible causes for citrate reactions include but are not limited to ac management during the procedure, and/or donor sensitivity to anticoagulant.Possible causes for the alleged vasovagal reaction include but are not the donor's sensitivity to the procedure.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL RBC PLT/PLASMA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10097503
• Report Number: 1722028-2020-00255
• Device Sequence Number: 19717757
• Product Code: GKT
• UDI-Device Identifier: 05020583804005
• UDI-Public: 05020583804005
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 80400
• Device Catalogue Number: 80400
• 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: 05/06/2020
• Supplement Date Received by Manufacturer: 02/22/2021; 03/22/2021
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 03/10/2021; 04/01/2021
• 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; Required Intervention