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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
Catalog Number 4824062
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not identify a conclusive root cause for the presence of air in the donor return lines for this procedure.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Specifically, the pressure signals and the pumped volume values were all within the expected ranges during tubing set test, ac prime, and blood prime states of the procedure.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that during an allogenic platelet procedure on a trima device, air was seen in the line going back to donor during the first return.A total of two air bubbles were observed, the first was 1/2 inch long and the second was 1/4 inch long.The operator clamped line before air was returned to the donor.All leur connections were tight and there was no clotting in the channel or in the return reservoir.The blood diversion pouch was not inflated with air.The operator reported the donor was not connected prior to ac prime and no air was being drawn in through the ac line or filter.No medical intervention was reported, and the patient is reported as stable and released home.Terumo bct is awaiting return of the disposable set for evaluation.
 
Event Description
The customer reported that during an allogenic platelet procedure on a trima device, air was seen in the line going back to donor during the first return.A total of two air bubbles were observed, the first was 1/2 inch long and the second was 1/4 inch long.The operator clamped line before air was returned to the donor.All leur connections were tight and there was no clotting in the channel or in the return reservoir.The blood diversion pouch was not inflated with air.The operator reported the donor was not connected prior to ac prime and no air was being drawn in through the ac line or filter.No medical intervention was reported, and the patient is reported as stable and released home.Terumo bct is awaiting return of the disposable set for evaluation.
 
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not identify a conclusive root cause for the presence of air in the donor/return lines for this procedure.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Specifically, the pressure signals and the pumped volume values were all within the expected ranges during tubing set test, ac prime, and blood prime states of the procedure.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.The customer history report indicates there were other reports of a similar issue.A disposable complaint history search was performed for this lot and found two reports for similar issues on this lot.Investigation is in process, a follow-up report will be provided.
 
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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 Key19020117
MDR Text Key339219671
Report Number1722028-2024-00114
Device Sequence Number1
Product Code GKT
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 04/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4824062
Device Lot Number2308032142
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/03/2023
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;
Patient Age43 YR
Patient SexMale
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