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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET
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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET Back to Search Results
Catalog Number 5823212
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problem Hemolysis (1886)
Event Date 02/09/2023
Event Type  malfunction  
Manufacturer Narrative
Manufacture, expiry and lot number are not available at this time.Investigation: a terumo bct service technician was able to confirm the reported condition at the customer site.The pressure sensors and level sensors were checked and an autotest was performed and completed and no fault was apparent.The machine was functioning correctly and was returned to service.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that there was possible hemolysis during a procedure.Approximately 15 mins in to donation a very small amount of pink was noticed in platelets and very pink plasma bag.The donation was stopped, but the donor felt well with no symptoms.No action was taken at the time of the procedure.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.The disposables set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a terumo bct service technician was able to confirm the reported condition at the customer site.The pressure sensors and level sensors were checked and an autotest was performed and completed and no fault was apparent.The machine was functioning correctly and was returned to service.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that this event was not hemolysis, it was red cell spill over caused by the lipemia.No further reporting will be provided as this does not represent a reportable event.
 
Event Description
The customer reported that there was possible hemolysis during a procedure.Approximately 15 mins in to donation a very small amount of pink was noticed in platelets and very pink plasma bag.The donation was stopped, but the donor felt well with no symptoms.No action was taken at the time of the procedure.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.The disposables set is not available for return because it was discarded by the customer.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
Manufacturer (Section G)
TERUMO BCT
10810 w. collins ave
lakewood CO 80215
Manufacturer Contact
scot hilden
10810 w. collins ave
lakewood, CO 80215
MDR Report Key16486795
MDR Text Key310802594
Report Number1722028-2023-00094
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/06/2023
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
Device Operator Health Professional
Device Catalogue Number5823212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2023
Initial Date FDA Received03/06/2023
Supplement Dates Manufacturer Received03/22/2023
Supplement Dates FDA Received03/29/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/02/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
Patient SexMale
Patient Weight80 KG
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