MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS, PLT + AUTO PAS, PLS S

Catalog Number 82321

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2022

Event Type  malfunction  

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 air in sample pouch experienced by the customer.Quality labs passed and sterilization requirements passed.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Corrective action: 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 during a collection, the sample pouch filled with air while collecting samples.Per the customer, the harness was checked fully prior to venipuncture.The donation was stopped immediately.Due to eu personal data protection laws, the patient information is not available from the customer.Donation number: g0956221298922.The customer is not able to return this set due to covid restrictions.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 device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the air in sample pouch experienced by the customer.Quality labs passed and sterilization requirements passed.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The run data file (rdf) was analyzed for this event.Corrective action: 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.The ¿pressure test error¿ alert was generated in this procedure because the system cannot maintain pressure.The run data file analysis did not show a conclusive root cause for what generated this ¿pressure test error¿ alert, however, it is possible the pinch clamp on the sample bag line was not occluding the line properly.If the clamp on the sample bag line is not occluding properly during the tubing set test, air can have a pathway to enter the sample bag.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.

Event Description

The customer reported that during a collection, the sample pouch filled with air while collecting samples.Per the customer, the harness was checked fully prior to venipuncture.The donation was stopped immediately.Due to eu personal data protection laws, the patient information is not available from the customer.Donation number: (b)(4) the customer is not able to return this set due to covid restrictions.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.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS, PLT + AUTO PAS, PLS S
• 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: 14307314
• MDR Text Key: 299709426
• Report Number: 1722028-2022-00148
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: BK190332
• 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
• Report Date: 05/05/2022

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 Date: 02/01/2024
• Device Catalogue Number: 82321
• Device Lot Number: 2202101130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2022
• 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