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

Model Number	80440
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number and expiry are not available at this time.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
A terumo bct associate reported that 30 minutes after a donor (a relative) left the blood center, she got dizzy and fell down, severely cutting her forehead and eyelid.She was transported to an emergency room and received 6 stitches on her forehead and another 6 stitches on the eyelid.The donor was treated and released.Patient id, age, and weight are not available at this time.The disposable set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer declined to provide patient information and additional procedural details for this event.
Additional Manufacturer Narrative
Investigation: the customer did not provide the lot number of the device used.A dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Since the lot number was not provided, a disposable lot history search could not be performed.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.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h6 & h10.Root cause: a definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLATELET+SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10101482
• Report Number: 1722028-2020-00261
• Device Sequence Number: 2400430
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• 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): 05/29/2020

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: 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: 05/07/2020
• Supplement Date Received by Manufacturer: 02/09/2021; 02/23/2021
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 02/22/2021; 03/16/2021
• 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