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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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation: 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.The run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was likely a result of an escape of wbcs from the lrs chamber that began near the start of the collection.Based on the signals, it cannot be ruled out that this disruption may have been due to an occlusion or air block in the plasma line in the centrifuge that disrupted the steady state of the system.Additionally, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.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)(4) the platelet collection is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: 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.The run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was likely a result of an escape of wbcs from the lrs chamber that began near the start of the collection.Based on the signals, it cannot be ruled out that this disruption may have been due to an occlusion or air block in the plasma line in the centrifuge that disrupted the steady state of the system.Additionally, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was likely a result of an escape of wbcs from the lrs chamber that began near the start of the collection.Based on the signals, it cannot be ruled out that this disruption may have been due to an occlusion or air block in the plasma line in the centrifuge that disrupted the steady state of the system.Additionally, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.
 
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.
 
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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 Key12849070
MDR Text Key282194188
Report Number1722028-2021-00357
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583824065
UDI-Public05020583824065
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
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2023
Device Model Number82406
Device Catalogue Number82406
Device Lot Number2108121130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/18/2021
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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