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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC SET
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TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC SET Back to Search Results
Model Number 82446
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 10/08/2021
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.Donor unit #: (b)(6) 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.The platelet collection set 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 towards the end of the collection.Based on the available information that the donor has contaminated before and that the donor had an elevated wbc count on the day of collection, it 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 b.6, 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 towards the end of the collection.Based on the available information that the donor has contaminated before and that the donor had an elevated wbc count on the day of collection, it 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 towards the end of the collection.Based on the available information that the donor has contaminated before and that the donor had an elevated wbc count on the day of collection, it 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.Donor unit #: (b)(6) 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.The platelet collection set is not available for return because it was discarded by the customer.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA PLATELET+SAMPLER, 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 Key12934042
MDR Text Key286664664
Report Number1722028-2021-00372
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583824461
UDI-Public05020583824461
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 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2023
Device Model Number82446
Device Catalogue Number5824462
Device Lot Number2104114151
Was Device Available for Evaluation? No
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/02/2021
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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