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

Model Number 80440

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Investigation is in process.A follow-up report will be provided.

Event 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 Description

The customer declined to provide patient information and additional procedural details for this event.

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.

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
• Type of Device: TRIMA PLATELET+SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10101482
• MDR Text Key: 196559610
• Report Number: 1722028-2020-00261
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804401
• UDI-Public: 05020583804401
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 80440
• Device Catalogue Number: 80440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 02/09/2021; 02/23/2021
• Supplement Dates FDA Received: 02/22/2021; 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention