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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET
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TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET Back to Search Results
Catalog Number 82321
Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2022
Event Type  malfunction  
Event Description
The customer reported that on set up the machine alarmed - pressure fault.Upon examination, the clamps were correct but the sample pouch was full of air.No patient (donor) was connected at the time of the event.The disposables set is not available for return because it was discarded by the customer.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 is in process.A follow-up report will be provided.
 
Event Description
The customer reported that on set up the machine alarmed - pressure fault.Upon examination, the clamps were correct but the sample pouch was full of air.No patient (donor) was connected at the time of the event.The disposables set is not available for return because it was discarded by the customer.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: 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.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag.Correction: trima field action 35 has been initiated to notify all trima users of a potential safety hazard occurs if the system displays an alert and instructions are not observed and followed.Terumo bct is taking corrective action by reminding all users of the action to be taken to mitigate this risk.Alerts and instructions are presented to the operator if the sample bag inflates.Terumo bct instructs all trima users to provide supplementary training and to continue to use the trima accel system in accordance with the operator¿s manual.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.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.Corrective action: an internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag.Correction: trima field action 35 has been initiated to notify all trima users of a potential safety hazard occurs if the system displays an alert and instructions are not observed and followed.Terumo bct is taking corrective action by reminding all users of the action to be taken to mitigate this risk.Alerts and instructions are presented to the operator if the sample bag inflates.Terumo bct instructs all trima users to provide supplementary training and to continue to use the trima accel system in accordance with the operator¿s manual.Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer reported that on set up the machine alarmed - pressure fault.Upon examination, the clamps were correct but the sample pouch was full of air.After multiple follow-up attempts, no additional procedural details were provided by the customer.No patient (donor) was connected at the time of the event as the issue was found prior to donor connect.The disposables set is not available for return because it was discarded by the customer.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 reported that on set up the machine alarmed - pressure fault.Upon examination, the clamps were correct but the sample pouch was full of air.After multiple follow-up attempts, no additional procedural details were provided by the customer.No patient (donor) was connected at the time of the event as the issue was found prior to donor connect.The disposables set is not available for return because it was discarded by the customer.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
This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in 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.Correction: trima field action 35 has been initiated to notify all trima users of a potential safety hazard occurs if the system displays an alert and instructions are not observed and followed.Terumo bct is taking corrective action by reminding all users of the action to be taken to mitigate this risk.Alerts and instructions are presented to the operator if the sample bag inflates.Terumo bct instructs all trima users to provide supplementary training and to continue to use the trima accel system in accordance with the operator¿s manual.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: - a clamp malfunction where the clamp skews to the side as it is closed - the clamp does not fully occlude the tubing when closed due to interference between the clamp and the tube.Additional contributing factors could be related to user interface, where either the sample bag clamp was not closed at the system prompt or the clamp was closed but it was skewed on the tubing enabling a portion of the tubing to allow air to pass.Corrected corrective action: the internal capa has been initiated to evaluate the sidewall pinch clamp and air in the sample bag is no longer applicable for this event.
 
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Brand Name
TRIMA ACCEL
Type of Device
TRIMA ACCEL LRS, PLT + AUTO PAS, PLS 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 Key13535952
MDR Text Key288366717
Report Number1722028-2022-00044
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup
Report Date 02/15/2022
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 Date08/01/2023
Device Catalogue Number82321
Device Lot Number2108272130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/21/2022
Initial Date FDA Received02/15/2022
Supplement Dates Manufacturer Received04/14/2022
04/14/2022
04/14/2022
Supplement Dates FDA Received03/11/2022
04/05/2022
04/28/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2021
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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