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 01/22/2024

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.Based on the image taken and the known diameter of the tubing, we can conservatively calculate the amount present past the final point of detection to be 0.052 ml.Based on a patient bodyweight of 189 lbs (86 kg), we can calculate the worst case ml/kg air transfusion dose to be 0.00060 ml/kg in this situation.One used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set and the platelet bags were removed.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.All pressure sensors were inspected and determined to be functioning properly.Gravity was used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All clamps were checked and were functional.No bond gaps were observed.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 was five reports of similar issues.Investigation is in process and a follow up report will be provided.

Event Description

The customer reported air was noticed in the needle line during first return of a procedure of an apheresis platelet procedure on a trima device.Three small bubbles made their way to the donor.The terumo bct clinical specialist, who was onsite, spoke to the operators who were running the procedure and saw something quickly flash down the return line that they saw resolve to a air bubble by the time it made it past the manifold and into the needle line.The operator reported all luer connections were tight and there was no clotting in the channel or reservoir.The blood diversion pouch was not inflated with air.The operator reported the donor was not connected prior to ac prime and no air was being drawn in through the ac line or filter.No medical intervention was required, the donor waited in the canteen and didn't experience any symptoms.Full donor unit id#: (b)(6).Donor gender and weight are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.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.Based on the image taken and the known diameter of the tubing, we can conservatively calculate the amount present past the final point of detection to be 0.052 ml.Based on a patient bodyweight of 189 lbs (86 kg), we can calculate the worst-case ml/kg air transfusion dose to be 0.00060 ml/kg in this situation.One used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set and the platelet bags were removed.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.All pressure sensors were inspected and determined to be functioning properly.Gravity was used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All clamps were checked and were functional.No bond gaps were observed.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 was five reports of similar issues.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process and a follow-up report will be provided.

Event Description

The customer reported air was noticed in the needle line during first return of a procedure of an apheresis platelet procedure on a trima device.Three small bubbles made their way to the donor.The terumo bct clinical specialist, who was onsite, spoke to the operators who were running the procedure and saw something quickly flash down the return line that they saw resolve to a air bubble by the time it made it past the manifold and into the needle line.The operator reported all luer connections were tight and there was no clotting in the channel or reservoir.The blood diversion pouch was not inflated with air.The operator reported the donor was not connected prior to ac prime and no air was being drawn in through the ac line or filter.No medical intervention was required, the donor waited in the canteen and didn't experience any symptoms.Full donor unit id# (b)(6).Donor gender and weight are not available at this time.

• 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: 18712959
• MDR Text Key: 336085366
• Report Number: 1722028-2024-00051
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824065
• UDI-Public: 5020583824065
• 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: 02/15/2024

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: 2302236142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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