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U.S. Department of Health and Human Services

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

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TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER PLASMA RBC SET Back to Search Results
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.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA PLATELET+SAMPLER PLASMA RBC SET
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
MDR Report Key10101482
MDR Text Key196559610
Report Number1722028-2020-00261
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583804401
UDI-Public05020583804401
Combination Product (y/n)N
PMA/PMN Number
BK190332
Number of Events Reported1
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 Number80440
Device Catalogue Number80440
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 05/07/2020
Initial Date FDA Received05/29/2020
Supplement Dates Manufacturer Received02/09/2021
02/23/2021
Supplement Dates FDA Received02/22/2021
03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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