Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER PLS RBC AUTOPAS SET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER PLS RBC AUTOPAS SET Back to Search Results
Catalog Number 80420
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 08/16/2021
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.Wbc count is not available at this time.The platelet collection is not available for return because it was discarded by the customer.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.
 
Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file did not show an rbc spillover as reported in the complaint.The signal of the rbc detector is smooth throughout the procedure without any sign of rbcs passing the rbc detector.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.Wbc count is not available at this time.The platelet collection is not available for return because it was discarded by the customer.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.
 
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.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.
 
Manufacturer Narrative
This report is being filed to provide additional information in b.5 and b.6.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file did not show an rbc spillover as reported in the complaint.The signal of the rbc detector is smooth throughout the procedure without any sign of rbcs passing the rbc detector.Lot number and expiry information are not available at this time.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.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file did not show an rbc spillover as reported in the complaint.The signal of the rbc detector is smooth throughout the procedure without any sign of rbcs passing the rbc detector.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: review of the run data file did not show an rbc spillover as reported in the complaint.The signal of the rbc detector is smooth throughout the procedure without any sign of rbcs passing the rbc detector.Run data file analysis did not show a conclusive root cause for the higher than expected wbc content in the platelet product reported for this collection.Alerts that could contribute to wbc contamination of the platelet product, such as ¿centrifuge pressure high¿ or ¿rbc spillover¿, were not generated in this run.As the rbc detector cannot count the cells passing by, in order to generate a ¿potential wbc contamination detected¿ message, the rbc detector signals must see a significant change in the reflectance values.In this case, rbc detector reflectance signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.It is also possible, though not conclusive, that this leukoreduction failure may be donor related.A potential reason for this donor related leukoreduction failure may be, but is not limited to, a high wbc count.
 
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.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIMA ACCEL
Type of Device
TRIMA PLT SAMPLER PLS RBC AUTOPAS 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 Key12569007
MDR Text Key282289108
Report Number1722028-2021-00313
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeMU
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,Followup
Report Date 10/04/2021
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 Catalogue Number80420
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/09/2021
Initial Date FDA Received10/04/2021
Supplement Dates Manufacturer Received11/17/2021
09/16/2022
10/07/2022
Supplement Dates FDA Received11/19/2021
10/03/2022
10/17/2022
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;
-
-