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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS
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TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS Back to Search Results
Catalog Number 82383
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
Event Type  malfunction  
Event Description
The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.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 #: 62221739831 wbc count is not available at this time.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: one used trima set was received for investigation.Initial observations noted the needle, ac bag and product bags were rf sealed and removed prior to return.Blood is noted throughout the set.Visual inspection noted the mini pinch clamps were on the correct lines and in the closed position.The yellow pinch clamp was in the open position.The set was further inspected for any kinks, missing parts or misassembles and none were found.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 overflow into the platelet concentrate when the additive solution was added.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) wbc count is not available at this time.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
Investigation: one used trima set was received for investigation.Initial observations noted the needle, ac bag and product bags were rf sealed and removed prior to return.Blood is noted throughout the set.Visual inspection noted the mini pinch clamps were on the correct lines and in the closed position.The yellow pinch clamp was in the open position.The set was further inspected for any kinks, missing parts or misassembles and none were found.The run data file (rdf) was analyzed for this event.¿return pressure high¿ alerts will be generated when the system detects that the pressure in the donor¿s vein is higher than desired during the return cycle.Run data file analysis showed all access alerts generated appeared to be due to true donor access related issues based on the known pressure signals of inadequate donor access.Review of the rbc signal during platelet additive solution phase showed that the cassette was cleaned correctly, and no rbcs were detected at the end of the cassette cleaning phase.Signals from the run data file showed an increased divergence between the red and green signal of the rbc detector during the pas addition phase.These signals indicate the pas wasn't flowing as fully as it could, possibly caused by an incorrect primed filter on the pas line, the bag frangible not broken correctly or the yellow clamp on the pas line not opened fully.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: ¿return pressure high¿ alerts will be generated when the system detects that the pressure in the donor¿s vein is higher than desired during the return cycle.Run data file analysis showed all access alerts generated appeared to be due to true donor access related issues based on the known pressure signals of inadequate donor access.Review of the rbc signal during platelet additive solution phase showed that the cassette was cleaned correctly, and no rbcs were detected at the end of the cassette cleaning phase.Signals from the run data file showed an increased divergence between the red and green signal of the rbc detector during the pas addition phase.These signals indicate the pas wasn't flowing as fully as it could, possibly caused by an incorrect primed filter on the pas line, the bag frangible not broken correctly or the yellow clamp on the pas line not opened fully.
 
Event Description
The customer would like the run data file investigated to determine a possible cause for the overflow into the platelet concentrate when the additive solution was added.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) wbc count is not available.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 overflow into the platelet concentrate when the additive solution was added.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).Wbc count is not available at this time.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
Investigation: one used trima set was received for investigation.Initial observations noted the needle, ac bag and product bags were rf sealed and removed prior to return.Blood is noted throughout the set.Visual inspection noted the mini pinch clamps were on the correct lines and in the closed position.The yellow pinch clamp was in the open position.The set was further inspected for any kinks, missing parts or misassembles and none were found.Lot number and expiry information are not available at this time.The run data file (rdf) was analyzed for this event.¿return pressure high¿ alerts will be generated when the system detects that the pressure in the donor¿s vein is higher than desired during the return cycle.Run data file analysis showed all access alerts generated appeared to be due to true donor access related issues based on the known pressure signals of inadequate donor access.Review of the rbc signal during platelet additive solution phase showed that the cassette was cleaned correctly, and no rbcs were detected at the end of the cassette cleaning phase.Signals from the run data file showed an increased divergence between the red and green signal of the rbc detector during the pas addition phase.These signals indicate the pas wasn¿t flowing as fully as it could, possibly caused by an incorrect primed filter on the pas line, the bag frangible not broken correctly or the yellow clamp on the pas line not opened fully.Investigation is in process.A follow-up report will be provided.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS
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 Key14876706
MDR Text Key303266949
Report Number1722028-2022-00214
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeFR
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 06/30/2022
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 Expiration Date10/01/2023
Device Catalogue Number82383
Device Lot Number2110152130
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2022
Initial Date FDA Received06/30/2022
Supplement Dates Manufacturer Received06/30/2022
08/01/2022
09/02/2022
Supplement Dates FDA Received07/25/2022
08/19/2022
09/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2021
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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