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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 09/19/2023
Event Type  malfunction  
Event Description
The customer reported to terumo bct customer support that there was air in the sampling bag when installing the set on the trima machine.Per the customer the luers were tight and there was no clotting observed in the channel.No patient (donor) was connected at the time of the event, , therefore no patient information is reasonably known.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: the customer returned an unused trima disposable set for investigation.Initial observation noted the white pinch clamps on the donor line were in the closed position and the blue pinch clamp was in the open position upon receipt.Visual inspection confirmed the sample bag was completely inflated with air.The donor line was dissected and all three donor line clamps were flow tested and were confirmed to properly occlude the tubing when in the closed position.No damage or defects to the clamps was observed.No leaks, kinks, occlusions or misassemblies were observed.In summary no disposables defects were observed.Investigation is in process, a follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer returned an unused trima disposable set for investigation.Initial observation noted the white pinch clamps on the donor line were in the closed position and the blue pinch clamp was in the open position upon receipt.Visual inspection confirmed the sample bag was completely inflated with air.The donor line was dissected and all three donor line clamps were flow tested and were confirmed to properly occlude the tubing when in the closed position.No damage or defects to the clamps was observed.No leaks, kinks, occlusions or misassemblies were observed.In summary no disposables defects were observed.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.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported to terumo bct customer support that there was air in the sampling bag when installing the set on the trima machine.Per the customer the luers were tight and there was no clotting observed in the channel.No patient (donor) was connected at the time of the event, , therefore no patient information is reasonably known.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 to terumo bct customer support that there was air in the sampling bag when installing the set on the trima machine.Per the customer the luers were tight and there was no clotting observed in the channel.No patient (donor) was connected at the time of the event.Therefore no patient information is reasonably known.(b)(4).
 
Manufacturer Narrative
Investigation: the customer returned an unused trima disposable set for investigation.Initial observation noted the white pinch clamps on the donor line were in the closed position and the blue pinch clamp was in the open position upon receipt.Visual inspection confirmed the sample bag was completely inflated with air.The donor line was dissected and all three donor line clamps were flow tested and were confirmed to properly occlude the tubing when in the closed position.No damage or defects to the clamps was observed.No leaks, kinks, occlusions or misassemblies were observed.In summary no disposables defects were observed.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 history report indicates no further related issues have been reported for this customer.Correction: the customer accepted terumo bct's offer of operator retraining which was completed on (b)(6) 2024.Corrective action: terumo bct has an existing corrective action for this failure to reduce the potential for recurrence.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 Key17940605
MDR Text Key325745913
Report Number1722028-2023-00341
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
Report Date 10/16/2023
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 Number2304142542
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/21/2023
Initial Date FDA Received10/16/2023
Supplement Dates Manufacturer Received11/10/2023
02/21/2024
Supplement Dates FDA Received11/30/2023
03/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2023
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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