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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET + PLT FILTER + AUTO PAS, PLASMA, RBC + TLR FILTER SET
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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET + PLT FILTER + AUTO PAS, PLASMA, RBC + TLR FILTER SET Back to Search Results
Catalog Number 80483
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation: two used collection bags and a haemonetics lrp6 leukocyte removal filter for platelets were received for investigation.The filter appeared fully saturated and no visual defects were readily apparent.Flow testing confirmed fluid could move through the filter.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.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.Wbc count is not available at this time.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: two used collection bags and a haemonetics lrp6 leukocyte removal filter for platelets were received for investigation.The filter appeared fully saturated and no visual defects were readily apparent.Flow testing confirmed fluid could move through the filter.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: - donor specific physiology - sampling, calculation, or other process error - rbc spillover - centrifuge stopped - rbc detector calibration error - possible air block - the orientation of the tubing as loaded in the centrifuge hex holder and the compromised structural integrity of the plasma tubing.Effectively, there is a certain orientation in the hex holder that allows for the rbc line to lie on top of the plasma line and, under certain flow conditions, may cause the plasma line to pinch off.This in turn causes higher flow through the lrs chamber, which may lead to elevated levels of wbcs in the platelet 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.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.Wbc count was not provided by the customer.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL LRS PLATELET + PLT FILTER + AUTO PAS, PLASMA, RBC + TLR FILTER 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
3032314970
MDR Report Key12166983
MDR Text Key263458966
Report Number1722028-2021-00235
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeFR
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 07/14/2021
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 Expiration Date10/01/2022
Device Catalogue Number80483
Device Lot Number2010282130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2021
Initial Date FDA Received07/14/2021
Supplement Dates Manufacturer Received08/24/2022
Supplement Dates FDA Received08/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2020
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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