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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 03/18/2024
Event Type  malfunction  
Event Description
The customer reported that during and apheresis platelet procedure on a trima device, two small air bubbles were observed during the first return in the line going back to the donor.The operator clamped the line before air could be returned to the donor.Per the customer, the first air bubble was approximately 1/8" long and a second air bubble was approximately 1 ft proximal to the first, and about 1/4 inch long.All leur connections were tight and there was no clotting in the channel or in the return reservoir.They said the blood diversion pouch was not inflated with air, the donor was connected prior to ac prime, and there was no air being drawn in through the ac line or filter.No medical intervention was reported, and the donor was reported to be stable and was released home.The customer did not provide patient age.The platelet collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that during and apheresis platelet procedure on a trima device, two small air bubbles were observed during the first return in the line going back to the donor.The operator clamped the line before air could be returned to the donor.Per the customer, the first air bubble was approximately 1/8" long and a second air bubble was approximately 1 ft proximal to the first, and about 1/4 inch long.All leur connections were tight and there was no clotting in the channel or in the return reservoir.They said the blood diversion pouch was not inflated with air, the donor was connected prior to ac prime, and there was no air being drawn in through the ac line or filter.No medical intervention was reported, and the donor was reported to be stable and was released home.The customer did not provide patient age.The platelet collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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 Key19098140
MDR Text Key340109737
Report Number1722028-2024-00140
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
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2024
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/19/2024
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 Age12 MO
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