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

Catalog Number 4824062

Device Problem Insufficient Information (3190)

Patient Problem Air Embolism (1697)

Event Date 01/17/2024

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 line 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 range during tubing set test, ac prime, and blood prime states of the procedure.A used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.It was noted that the set was returned with the platelet bag, inlet needle and sample bag, and the ac spike were removed and sealed off.Visual inspection revealed 1.5 inches of air in the return pump header.Two air bubbles measuring at 1 mm were noted in the ac line.1mm of air bubble is observed on the tubing exiting 3 to 1 manifold of the inlet coil.The reservoir has bubbles in it and the level of blood only fills up to the top of the filter.Gravity was used to manipulate fluid throughout the set and no obstruction issues were noted.All clamps were checked and were functional.The red tubing bonded to the cassette has about.01mm bond gap, otherwise, no other bond gaps were noted on the set.Based on the images provided and the known diameter of the tubing, we can conservatively calculate the amount present past the final point of detection to be 0.32 ml.Based on a patient bodyweight of 195 lbs (88 kg), we can calculate the worst-case ml/kg air transfusion dose to be 0.0037 ml/kg in this situation.A disposable complaint history search was performed for this lot and found one report for similar issues on this lot.The customer history report indicates there were three other reports of similar issues within the same month, january 2024.Investigation is in process and a follow-up report will be provided.

Event Description

The customer reported that during an apheresis platelet procedure on a trima accel device air was observed in the return line during the first return.It was reported that some air went into the donor with approximately 1/2" of air remaining in the line.The donor was reported to be in stable condition.All leur connections were tight and there was no clotting in the channel or in the return reservoir.No medical intervention was reported.Full donor unit id# (b)(6).

• 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: 18678014
• MDR Text Key: 335087622
• Report Number: 1722028-2024-00048
• Device Sequence Number: 1
• Product Code: GKT
• 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: 02/09/2024

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 Catalogue Number: 4824062
• Device Lot Number: 2307282142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2023
• 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: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White