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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA, RBC SET
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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA, RBC SET Back to Search Results
Model Number 82406
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 11/26/2021
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.Donor unit #: (b)(6) 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.
 
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.Donor unit #: (b)(6) the platelet collection is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: multiple attempts were made to collect the information required to thoroughly investigate this complaint, but the correct information was not provided by the customer.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before 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.Donor unit #: (b)(6).The platelet collection is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: multiple attempts were made to collect the information required to thoroughly investigate this complaint, but the correct information was not provided by the customer.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.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: a higher-than-expected wbc content in the platelet product may be a result of an escape of wbc from the lrs chamber throughout the procedure.An occlusion or air block in the collect line may have occurred and disrupted the steady state of the system and the separation in the lrs chamber.Rbc spill over; centrifuge stopped; rbc detector calibration error; 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.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL PLATELET, PLASMA, RBC 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 Key13053911
MDR Text Key286920978
Report Number1722028-2021-00396
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583824065
UDI-Public05020583824065
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
BK190332
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,Followup
Report Date 12/21/2021
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 Model Number82406
Device Catalogue Number82406
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2021
Initial Date FDA Received12/21/2021
Supplement Dates Manufacturer Received07/07/2022
08/16/2022
Supplement Dates FDA Received07/08/2022
08/19/2022
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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