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

Catalog Number 82383

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

The customer reported that during the procedure of adding preservative solution, the "centrifuge clamp" alarm asks to check if they are properly closed.They were fine.The customer opened them and close them again, then pressed "continue".The "clamp" alarm occurred again.The customer performed the same manipulation as before and the alarm was triggered a 3rd time.The addition of preservative solution started, but with a very large passage of gr, resulting in an unusable product.The customer declined to provide further information regarding the event.There was not a transfusion recipient or patient involved at the time of the preservative solution addition, therefore no patient 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: one used trima set was received for investigation.Initial observations noted the ac bag and product bags were rf sealed and removed prior to return.Visual inspection noted blood in the set up to and in the channel, the reservoir, and the vent bag.Red fluid was observed in the plasma line from centrifuge and through the cassette, in the plasma and platelet pump header tubing, over the rbc detector and in the platelet line through the cassette and in the platelet line from centrifuge up to the y-connector.The mini pinch clamps were noted to be on the correct lines and in the closed position.They were observed to be occluding the lines effectively.The clamp on the pas line was not returned.The set was further inspected for any kinks, misassemblies or missing parts and none were found.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that during the procedure of adding preservative solution, the "centrifuge clamp" alarm asks to check if they are properly closed.They were fine.The customer opened them and close them again, then pressed "continue".The "clamp" alarm occurred again.The customer performed the same manipulation as before and the alarm was triggered a 3rd time.The addition of preservative solution started, but with a very large passage of gr, resulting in an unusable product.The customer declined to provide further information regarding the event.There was not a transfusion recipient or patient involved at the time of the preservative solution addition, therefore no patient 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

This report is being filed to provide additional information in b.6, h.6 and h.10.Investigation: one used trima set was received for investigation.Initial observations noted the ac bag and product bags were rf sealed and removed prior to return.Visual inspection noted blood in the set up to and in the channel, the reservoir, and the vent bag.Red fluid was observed in the plasma line from centrifuge and through the cassette, in the plasma and platelet pump header tubing, over the rbc detector and in the platelet line through the cassette and in the platelet line from centrifuge up to the y-connector.The mini pinch clamps were noted to be on the correct lines and in the closed position.They were observed to be occluding the lines effectively.The clamp on the pas line was not returned.The set was further inspected for any kinks, misassemblies or missing parts and none were found.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Signals in the run data file (rdf) indicated that the trima device operated as intended by flagging the procedure to verify wbcs.The run data file (rdf) was analyzed for this event.Root cause: review of the rbc signal during platelet additive solution phase showed the cassette was not cleaned properly and that rbcs were detected by the rbc detector at the beginning of the platelet additive solution phase.The verification during the addition phase is based on a change of the rbc detector reading.If the reading increases too much beyond the baseline, then a ¿channel line clamp error¿ alert is generated, as was the case in this procedure.It is possible, though not conclusive that one or more of the 3 channel lines were partially clamped and not fully occluded, or the frangible of the platelet additive solution bag was not fully broken or reseated.The procedure is flagged for potential wbc contamination.No further reporting will be provided as this does not represent a reportable event.

• 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: 14645061
• MDR Text Key: 301494536
• Report Number: 1722028-2022-00190
• 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
• Report Date: 06/09/2022

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: 05/01/2023
• Device Catalogue Number: 82383
• Device Lot Number: 2105252130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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