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

Catalog Number 82383

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer returned a trima set for investigation.Visual inspection confirmed the set appeared to be assembled properly with no obvious manufacturing defects.There were no leaks, missing parts, defects or occlusions identified.The kit was flow tested successively with no restrictions identified.Witness lines were not clear on the lower hex.The sample bag clamp was closed and sample bag tubing flow tested using a fluid filled syringe - fluid was not able to pass through the clamped tubing.As stated by the customer it was noted that the sample bag was full of air.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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.Correction: terumo bct has offered customer retraining for this issue.Terumobct regional sales support specialist confirmed that the retraining was completed 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 while installing the set for an apheresis procedure, the sample bag filled with air while the clamp was closed.This was noticed before a donor was connected.The set was replaced with a new set.There was not a donor involved at the time of this incident, therefore no donor information is reasonably known at the time of the event.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 a trima set for investigation.Visual inspection confirmed the set appeared to be assembled properly with no obvious manufacturing defects.There were no leaks, missing parts, defects or occlusions identified.The kit was flow tested successively with no restrictions identified.Witness lines were not clear on the lower hex.The sample bag clamp was closed and sample bag tubing flow tested using a fluid filled syringe - fluid was not able to pass through the clamped tubing.As stated by the customer it was noted that the sample bag was full of air.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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.Correction: terumo bct has offered customer retraining for this issue.Terumobct regional sales support specialist confirmed that the retraining was completed 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.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: 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.

Event Description

The customer reported that while installing the set for an apheresis procedure, the sample bag filled with air while the clamp was closed.This was noticed before a donor was connected.The set was replaced with a new set.There was not a donor involved at the time of this incident, therefore no donor information is reasonably known at the time of the event.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 LRS PLT W/FILTER+SAMPLER+AUT
• 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: 14575841
• MDR Text Key: 301197136
• Report Number: 1722028-2022-00175
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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: 12/01/2023
• Device Catalogue Number: 82383
• Device Lot Number: 2112062130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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