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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 4823832
Device Problems Use of Device Problem (1670); Insufficient Information (3190); Device Handling Problem (3265)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2023
Event Type  malfunction  
Event Description
The customer reported that at the end of priming the set it was noticed that an abnormal noise was coming from the return rotor and that the sampling bag was inflated and under pressure.Customer stated that the needle clamps were in place and that the sampling clamps were slightly offset on the tubing.The vent bag was not impacted and it remained flat.The customer put the set aside as a precaution.Per the customer, the luer connections were tight and air was not drawn in through the ac filter.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.Terumo bct is awaiting return of the disposable set for evaluation.There was no donor information as the procedure was discontinued prior to connecting donor.
 
Manufacturer Narrative
Investigation: 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.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The customer submitted two photographs to aid investigation.One image shows the trima alarm screen and confirms the alarm 'pressure test error', and suggests to check that the donor line and sample line clamps are closed, that the sampling bag doesn't contain air, that the tubing around the pumps are loaded correctly, and that the cassette is loaded correctly.The second image shows the sample bag, the vent bag, the needle and a section of the donor line.The operator is observed to be holding the sample bag which is fully inflated with air.The vent bag is noted to be flat and does not contain air.The white pinch clamp on the donor line is noted to be in the closed position.Corrective action: terumo bct has an existing corrective action for this failure to reduce the potential for recurrence.Investigation is in process, a follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: 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.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The customer submitted two photographs to aid investigation.One image shows the trima alarm screen and confirms the alarm 'pressure test error', and suggests to check that the donor line and sample line clamps are closed, that the sampling bag doesn't contain air, that the tubing around the pumps are loaded correctly, and that the cassette is loaded correctly.The second image shows the sample bag, the vent bag, the needle and a section of the donor line.The operator is observed to be holding the sample bag which is fully inflated with air.The vent bag is noted to be flat and does not contain air.The white pinch clamp on the donor line is noted to be in the closed position.The customer returned an unused trima disposable set for investigation.Visual inspection confirmed the sample bag was almost completely inflated with air.The white pinch clamps on the donor line/sample bag line were returned in the closed position.The blue pinch clamp on the donor line was returned in the open position.No damage was observed to the clamps/tubing.The set was successfully loaded onto a trima device in the laboratory.Pressure tests were completed without incident and the system proceeded to ac prime.The sample bag was noted to deflate slightly but some air still remained within the sample bag.The set was unloaded from the trima device and the donor line was flow tested with all 3 clamps (2 white and 1 blue) in the closed position.All 3 clamps were found to successfully occlude the donor line when in the closed position.The set was further inspected and no kinks, leaks, misassemblies, missing parts or occlusions were identified.In summary, no disposable defects were identified.Corrective action: terumo bct has an existing corrective action for this failure to reduce the potential for recurrence.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that at the end of priming the set it was noticed that an abnormal noise was coming from the return rotor and that the sampling bag was inflated and under pressure.Customer stated that the needle clamps were in place and that the sampling clamps were slightly offset on the tubing.The vent bag was not impacted and it remained flat.The customer put the set aside as a precaution.Per the customer, the luer connections were tight and air was not drawn in through the ac filter.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.There was no donor information as the procedure was discontinued prior to connecting donor.
 
Event Description
The customer reported that at the end of priming the set it was noticed that an abnormal noise was coming from the return rotor and that the sampling bag was inflated and under pressure.Customer stated that the needle clamps were in place and that the sampling clamps were slightly offset on the tubing.The vent bag was not impacted and it remained flat.The customer put the set aside as a precaution.Per the customer, the luer connections were tight and air was not drawn in through the ac filter.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.There was no donor information as the procedure was discontinued prior to connecting donor.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: 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.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The customer submitted two photographs to aid investigation.One image shows the trima alarm screen and confirms the alarm 'pressure test error', and suggests to check that the donor line and sample line clamps are closed, that the sampling bag doesn't contain air, that the tubing around the pumps are loaded correctly, and that the cassette is loaded correctly.The second image shows the sample bag, the vent bag, the needle and a section of the donor line.The operator is observed to be holding the sample bag which is fully inflated with air.The vent bag is noted to be flat and does not contain air.The white pinch clamp on the donor line is noted to be in the closed position.The customer returned an unused trima disposable set for investigation.Visual inspection confirmed the sample bag was almost completely inflated with air.The white pinch clamps on the donor line/sample bag line were returned in the closed position.The blue pinch clamp on the donor line was returned in the open position.No damage was observed to the clamps/tubing.The set was successfully loaded onto a trima device in the laboratory.Pressure tests were completed without incident and the system proceeded to ac prime.The sample bag was noted to deflate slightly but some air still remained within the sample bag.The set was unloaded from the trima device and the donor line was flow tested with all 3 clamps (2 white and 1 blue) in the closed position.All 3 clamps were found to successfully occlude the donor line when in the closed position.The set was further inspected and no kinks, leaks, misassemblies, missing parts or occlusions were identified.In summary, no disposable defects were identified.Corrective action: terumo bct has an existing corrective action for this failure to reduce the potential for recurrence.Correction: retraining of the relevant customer teams was completed at the customer site.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that at the end of priming the set it was noticed that an abnormal noise was coming from the return rotor and that the sampling bag was inflated and under pressure.Customer stated that the needle clamps were in place and that the sampling clamps were slightly offset on the tubing.The vent bag was not impacted and it remained flat.The customer put the set aside as a precaution.Per the customer, the luer connections were tight and air was not drawn in through the ac filter.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.There was no donor information as the procedure was discontinued prior to connecting donor.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The customer submitted two photographs to aid investigation.One image shows the trima alarm screen and confirms the alarm 'pressure test error', and suggests to check that the donor line and sample line clamps are closed, that the sampling bag doesn't contain air, that the tubing around the pumps are loaded correctly, and that the cassette is loaded correctly.The second image shows the sample bag, the vent bag, the needle and a section of the donor line.The operator is observed to be holding the sample bag which is fully inflated with air.The vent bag is noted to be flat and does not contain air.The white pinch clamp on the donor line is noted to be in the closed position.The customer returned an unused trima disposable set for investigation.Visual inspection confirmed the sample bag was almost completely inflated with air.The white pinch clamps on the donor line/sample bag line were returned in the closed position.The blue pinch clamp on the donor line was returned in the open position.No damage was observed to the clamps/tubing.The set was successfully loaded onto a trima device in the laboratory.Pressure tests were completed without incident and the system proceeded to ac prime.The sample bag was noted to deflate slightly but some air still remained within the sample bag.The set was unloaded from the trima device and the donor line was flow tested with all 3 clamps (2 white and 1 blue) in the closed position.All 3 clamps were found to successfully occlude the donor line when in the closed position.The set was further inspected and no kinks, leaks, misassemblies, missing parts or occlusions were identified.In summary, no disposable defects were identified.Corrective action: terumo bct has an existing corrective action for this failure to reduce the potential for recurrence.Correction: retraining of the relevant customer teams was completed at the customer site.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause is likely due to one or a combination of the possible causes listed below: * the sample bag clamp was not closed at the system prompt.* the clamp was closed but it was skewed on the tubing enabling a portion of the tubing to allow air to pass.
 
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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 Key17003912
MDR Text Key316022955
Report Number1722028-2023-00189
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 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 Catalogue Number4823832
Device Lot Number2208052142
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2023
Initial Date FDA Received05/25/2023
Supplement Dates Manufacturer Received06/06/2023
12/05/2023
01/05/2024
Supplement Dates FDA Received06/19/2023
12/28/2023
01/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2022
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;
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