MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT W/FILTER+SAMPLER+AUTOPAS_

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.

• 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 Key: 17003912
• MDR Text Key: 316022955
• Report Number: 1722028-2023-00189
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• 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 Number: 4823832
• Device Lot Number: 2208052142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/06/2023; 12/05/2023; 01/05/2024
• Supplement Dates FDA Received: 06/19/2023; 12/28/2023; 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other