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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 Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2023
Event Type  malfunction  
Manufacturer Narrative
Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: tbct clinical support offered retraining to the customer.Clinical support also provided instructions for raising the cassette manually to clear alarm (32785) system test failure - detected invalid state transition.Raising the cassette tray resolved the alarm issue.Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer reported that they tried to load a set and noticed that the platelet pump was in the wrong location.She corrected the pump location and performed the venipuncture before the cassette was lowered and primed.She then collected the blood samples and but, was unable to lower the cassette do to alarms.She then removed the set from the trima with the needle in the donors arm and loaded the set on a different trima.She was unable to continue because the needle clotted off.There were no ill affects to the donor and no medical intervention was required.Full patient id: (b)(6).The customer was unable to provide the donor's age/date of birth.The collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: tbct clinical support offered retraining to the customer on may 5th.The customer declined the offer of retraining stating they were reviewing the issue with their staff internally and would reach out if any assistance was needed.They did not contact terumo bct for further assistance on retraining clinical support also provided instructions for raising the cassette manually to clear alarm (32785) system test failure - detected invalid state transition.Raising the cassette tray resolved the alarm issue.Root cause: a root cause assessment was performed for this complaint.Based on the available information, the root cause of the potential of air to donor was due to an operator error where they connected the donor too soon and before lowering and priming the set.
 
Event Description
The customer reported that they tried to load a set and noticed that the platelet pump was in the wrong location.She corrected the pump location and performed the venipuncture before the cassette was lowered and primed.She then collected the blood samples and but, was unable to lower the cassette do to alarms.She then removed the set from the trima with the needle in the donors arm and loaded the set on a different trima.She was unable to continue because the needle clotted off.There were no ill affects to the donor and no medical intervention was required.Full patient id: (b)(6).The customer declined to provide the donor's age.The 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 Key17005361
MDR Text Key316022942
Report Number1722028-2023-00190
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/25/2023
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 Model Number82446
Device Catalogue Number5824462
Device Lot Number2212054251
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/04/2023
Initial Date FDA Received05/25/2023
Supplement Dates Manufacturer Received10/13/2023
Supplement Dates FDA Received10/17/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/02/2022
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 SexMale
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