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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 10/11/2021
Event Type  malfunction  
Event Description
The customer would like an investigation to determine a possible cause for the higher-than-expected 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: 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 possibly a result of an escape of wbcs from the lrs chamber during the collection.The signals also show that the device was having difficulty maintaining steady state during the spate of pressure alerts toward the end of the collection.It cannot be ruled out that the needle line access may have shifted and caused the sudden number of ¿draw pressure too low¿ alerts that affected the flow rate.Based on the available information, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor related.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.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.3.Investigation: 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 possibly a result of an escape of wbcs from the lrs chamber during the collection.The signals also show that the device was having difficulty maintaining steady state during the spate of pressure alerts toward the end of the collection.It cannot be ruled out that the needle line access may have shifted and caused the sudden number of ¿draw pressure too low¿ alerts that affected the flow rate.Based on the available information, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor related.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: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbcs from the lrs chamber during the collection.The signals also show that the device was having difficulty maintaining steady state during the spate of pressure alerts toward the end of the collection.It cannot be ruled out that the needle line access may have shifted and caused the sudden number of ¿draw pressure too low¿ alerts that affected the flow rate.Based on the available information, 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 an investigation to determine a possible cause for the higher-than-expected 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 Key12760641
MDR Text Key286663906
Report Number1722028-2021-00352
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 Administrator/Supervisor
Type of Report Initial,Followup
Report Date 11/05/2021
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 Date07/01/2023
Device Model Number82406
Device Catalogue Number5824061
Device Lot Number2107024351
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/12/2021
Initial Date FDA Received11/07/2021
Supplement Dates Manufacturer Received02/01/2022
Supplement Dates FDA Received02/07/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2021
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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