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 03/04/2024

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.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 twelve reports of a similar issue.A disposable complaint history search was performed for this lot and found one other report for similar issue on this lot, from the same customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during an allogenic platelet procedure on a trima device a small air bubble, approximately 1/8th inch, was seen in the line going back to the donor during the first return.The operator clamped the line before air was returned to the donor.No medical intervention was reported, and the patient is reported as stable and release home.Full donor id #: (b)(6) the customer reported that all luer connections were tight and there was no clotting in the channel or reservoir.The blood diversion pouch was not inflated with air and the donor was not connected prior to ac prime.The customer stated that no air was being drawn in through the ac line or filter.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: 18990530
• MDR Text Key: 339035662
• Report Number: 1722028-2024-00107
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 03/05/2024
• 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: 29 YR
• Patient Sex: Male