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 01/13/2024

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 images provided and the known diameter of the tubing, we can conservatively calculate the amount present past the final point of detection to be 0.66 ml.Based on a patient bodyweight of 285 lbs (129 kg), we can calculate the worst-case ml/kg air transfusion dose to be 0.0051 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 and plasma 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.Initial visual inspection revealed air in the return pumpheader tubing approximately 0.73 of an inch.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 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 that during an apheresis platelet procedure air was observed approximately two inches from the donor needle and approximately one inch from the y connector on the needle tubing during the first return.The staff immediately clamped the line, but a small air bubble went into the donor.The procedure was aborted, and the patient was monitored for 30 minutes in the canteen and had no symptoms.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)(4) the customer did not provide patient age.

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 images provided and the known diameter of the tubing, we can conservatively calculate the amount present past the final point of detection to be 0.66 ml.Based on a patient bodyweight of 285 lbs (129 kg), we can calculate the worst-case ml/kg air transfusion dose to be 0.0051 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 and plasma 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.Initial visual inspection revealed air in the return pumpheader tubing approximately 0.73 of an inch.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 review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Investigation is in process and a follow-up report will be provided.

Event Description

The customer reported that during an apheresis platelet procedure air was observed approximately two inches from the donor needle and approximately one inch from the y connector on the needle tubing during the first return.The staff immediately clamped the line, but a small air bubble went into the donor.The procedure was aborted, and the patient was monitored for 30 minutes in the canteen and had no symptoms.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).The customer did not provide patient age.

Event Description

The customer reported that during an apheresis platelet procedure air was observed approximately two inches from the donor needle and approximately one inch from the y connector on the needle tubing during the first return.The staff immediately clamped the line, but a small air bubble went into the donor.The procedure was aborted, and the patient was monitored for 30 minutes in the canteen and had no symptoms.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) the customer did not provide patient age.

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 images provided and the known diameter of the tubing, we can conservatively calculate the amount present past the final point of detection to be 0.66 ml.Based on a patient bodyweight of 285 lbs (129 kg), we can calculate the worst-case ml/kg air transfusion dose to be 0.0051 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 and plasma 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.Initial visual inspection revealed air in the return pumpheader tubing approximately 0.73 of an inch.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 review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A terumo bct clinical specialist visited the customer site to observe further procedures and found the operators were clamping and sealing everything correctly.The customer history report indicates there were seven reports of similar issues.Investigation is in process and a follow-up report will be provided.

• 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: 18659207
• MDR Text Key: 334757606
• Report Number: 1722028-2024-00042
• 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,Followup
• Report Date: 02/07/2024

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: 2303296242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/27/2024; 04/18/2024
• Supplement Dates FDA Received: 04/18/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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 Sex: Male