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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA
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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL RBC PLT/PLASMA Back to Search Results
Model Number 80400
Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2022
Event Type  malfunction  
Event Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Wbc count is not available at this time.The platelet collection is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.10.Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Wbc count is not available at this time.The platelet collection 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: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: a root cause assessment was performed for this complaint.There are various reasons for elevated wbc levels in collected product such as donor factors, kit misloads, airblocks, disposable set deviations, paused centrifuge, or other processing difficulty in maintaining the steady state necessary to efficiently separate blood components.Regarding donor factors, there appears to be patterns with repeat donors that produce platelet products with high wbc counts.Saturation events leading to elevated wbcs in collected product are also possible if the donor pre-counts are entered falsely much lower than actual as this can cause the lrs chamber to fill before the system expects and wbcs to escape before detection.Misloading of a set or disposable set deviation may cause a plasma line occlusion or an air block within the centrifuge which may lead to the white blood cells getting flushed out of the lrs chamber into the product.
 
Event Description
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Wbc count is not available at this time.The platelet collection 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 RBC PLT/PLASMA
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 Key13839965
MDR Text Key297870142
Report Number1722028-2022-00089
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583804005
UDI-Public05020583804005
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK190332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number80400
Device Catalogue Number80400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2023
Was Device Evaluated by Manufacturer? No
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;
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