MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA, RBC SET

Catalog Number 4824062

Device Problem Insufficient Information (3190)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not identify a conclusive root cause for the presence of air in the donor/return lines for this procedure.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Specifically, the pressure signals and the pumped volume values were all within the expected ranges during tubing set test, ac prime, and blood prime states of the procedure.The operator reported that this was the first time they observed this type of event.They also reported that they were given specific instructions to watch for air in the return line, and when asked, noted that this was not something they had always done historically.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a procedure on a trima device a total of three air bubbles were seen in the line going back to donor during the first return.The first air bubble (approximately one inch long) was observed in the needle line, on the donor side of the 3:1 manifold.The second air bubble (approximately one inch long) was observed approximately two feet up the line from the first air bubble in the return line.The third air bubble (approximately 0.25 inch long) was observed in the return line, near the cassette.The donation was stopped prior to the air bubble reaching the phlebotomy site.All leur connections were tight and there was no clotting in the channel or in the return reservoir.Per the customer, the blood diversion pouch was not inflated with air.The donor was stable and was released to home with no follow up.No medical intervention was reported.Full donor unit id# (b)(6) the platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.11.Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not identify a conclusive root cause for the presence of air in the donor/return lines for this procedure.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.Specifically, the pressure signals and the pumped volume values were all within the expected ranges during tubing set test, ac prime, and blood prime states of the procedure.The operator reported that this was the first time they observed this type of event.They also reported that they were given specific instructions to watch for air in the return line, and when asked, noted that this was not something they had always done historically.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.The customer history report indicates there were other reports of a similar issue.A disposable complaint history search was performed for this lot and found two reports for similar issues on this lot.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a procedure on a trima device a total of three air bubbles were seen in the line going back to donor during the first return.The first air bubble (approximately one inch long) was observed in the needle line, on the donor side of the 3:1 manifold.The second air bubble (approximately one inch long) was observed approximately two feet up the line from the first air bubble in the return line.The third air bubble (approximately 0.25 inch long) was observed in the return line, near the cassette.The donation was stopped prior to the air bubble reaching the phlebotomy site.All leur connections were tight and there was no clotting in the channel or in the return reservoir.Per the customer, the blood diversion pouch was not inflated with air.The donor was stable and was released to home with no follow up.No medical intervention was reported.Full donor unit id# (b)(6) the platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• 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: 18970872
• MDR Text Key: 339038702
• Report Number: 1722028-2024-00102
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824065
• UDI-Public: 05020583824065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4824062
• Device Lot Number: 2303161142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Female