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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TIRMA ACCEL; TRIMA ACCEL AUTORBC, PLASMA SET
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TERUMO BCT TIRMA ACCEL; TRIMA ACCEL AUTORBC, PLASMA SET Back to Search Results
Model Number 82520
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 11/10/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.The signals in the rdf show that the trima operated as intended.Based on the available information, it cannot be ruled out that a possible filter misload or donor-related factors may have contributed to the higher-than-expected wbc content in the rbc product.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.
 
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 red blood cell 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 rdf show that the trima operated as intended.Based on the available information, it cannot be ruled out that a possible filter misload or donor-related factors may have contributed to the higher-than-expected wbc content in the rbc product.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: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined.However, based on the available information it cannot be ruled out that this failure may be related to either the donor or the loading of the auto rbc filter.Alternatively, some donor-related factors may contribute to an increased concentration of wbcs in the processed blood by the time the second unit is to be collected.
 
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 red blood cell 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
TIRMA ACCEL
Type of Device
TRIMA ACCEL AUTORBC, PLASMA 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 Key12934114
MDR Text Key286664838
Report Number1722028-2021-00373
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583825208
UDI-Public05020583825208
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 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 Number82520
Device Catalogue Number82520
Device Lot Number2104052130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/05/2021
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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