MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET

Catalog Number 5823212

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: a set was loaded and had an issue with the pump header not loading correctly.The set was removed, and a new set put on.The customer reported the donor received an air embolism.The donor care supervisor noted that the machine was set up correctly.After the first return, they noticed that 3cm of air was in the return blood line which was then sent to the donor during prime.The donor was sent to hospital as a precaution but remained well.No information on medical intervention at the hospital was available.Luer connections were noted to be tight, and the blood diversion pouch was inflated with air.No alarms occurred.No air was being drawn in through the ac line/filter and the customer noted no clotting in the channel or return reservoir.The run data file (rdf) was analyzed for this event.Run data file analysis showed the run was paused and terminated by the operator just after the third return cycle to the donor had completed.No alerts or alarms were generated during the tubing set test after the operator selected to load a new tubing set or during the collection prior to the operator pressing the pause button.Analysis showed the volume to prime the return line to the lower reservoir sensor with blood just after the donor was connected was within normal ranges.Additionally, the lower reservoir sensor did not detect air once filled with blood upon priming of the return line until the end of the first return cycle.Therefore, the observed air bubble in the return line is suspected to have been in the return 3-lumen line from the return line prime and not from the reservoir.Run data file analysis did not show a conclusive root cause for how air entered the return line during the return line prime.Possible causes include, but are not limited to: air bubble from the ac line.If the drip chamber was not filled properly or if the ac bag was not connected to the bag line properly, air could have entered the ac line.During return line prime, the ac pump runs with the return pump to ensure anticoagulation of the prime blood.Otherwise, the ac pump is turned off for return cycles.The run data file shows the ac sensor did not detect air following the connection of ac, so this failure mode is unlikely unless air came from the ac line below the ac sensor.Air bubble entered from the needle line if the needle was not inserted fully into the donor vein.If the sample bag was not completely sealed, it is possible for air to have been drawn into the line from the sample bag with the donor blood.¿ variations in the tubing set, such as a tubing set leak or bond error analysis of the run data file did not indicate any large volumes of air entered through the inlet line.If air was being drawn into the inlet line, the centrifuge pressure signals would be increased from normal levels.However, the centrifuge pressure in this procedure remained within normal levels.Additionally, the run data file showed the lower reservoir sensor was detecting air and fluid appropriately, as evidenced by detecting fluid during priming of the return line and air at the end of each return cycle.All return cycles were shown to have normal reservoir volumes so it is not suspected that the reservoir would have emptied by more than expected, allowing air to enter the line without the system detecting it.Signals from the reservoir appeared perfectly normal, meaning the reservoir seemed to be filling and emptying as expected with no suspected air or foam present.The device history records (dhr) were reviewed for this lot.  there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The customer returned a used trima disposable set for investigation.Blood was noted throughout the set.No air was observed in the return lines.The set was inspected for any kinks, missing parts, misassemblies or leaks and none were identified.No clotting or clumping was noted and there was no evidence of a misload.The set was flow tested using a fluid filled syringe via the ac line and the pas line and no occlusions were identified.In summary no disposable defects were identified.The customer returned a second unused trima disposable set.The set was inspected and no kinks, leaks, misassemblies, missing parts or occlusions were identified.The set was loaded into an in house trima device and proceeded to the necessary pressure and prime tests without any issues.In summary no defects were identified root cause: a root cause assessment was performed for this complaint.Based on the available information, the root cause of the tube set type error was a pump header not loading correctly.This cause of this issue could not be determined but it is likely due to one or a combination of the possible causes listed below: kinked tubing , tubing issue , obstruction underneath the cassette run data file analysis showed the run was paused and terminated by the operator just after the third return cycle to the donor had completed.No alerts or alarms were generated during the tubing set test after the operator selected to load a new tubing set or during the collection prior to the operator pressing the pause button.Analysis showed the volume to prime the return line to the lower reservoir sensor with blood just after the donor was connected was within normal ranges.Additionally, the lower reservoir sensor did not detect air once filled with blood upon priming of the return line until the end of the first return cycle.Therefore, the observed air bubble in the return line is suspected to have been in the return 3-lumen line from the return line prime and not from the reservoir.Run data file analysis did not show a conclusive root cause for how air entered the return line during the return line prime.Possible causes include but are not limited to: air bubble from the ac line.If the drip chamber was not filled properly or if the ac bag was not connected to the bag line properly, air could have entered the ac line.During return line prime, the ac pump runs with the return pump to ensure anticoagulation of the prime blood.Otherwise, the ac pump is turned off for return cycles.The run data file shows the ac sensor did not detect air following the connection of ac, so this failure mode is unlikely unless air came from the ac line below the ac sensor.Air bubble entered from the needle line if the needle was not inserted fully into the donor vein.If the sample bag was not completely sealed, it is possible for air to have been drawn into the line from the sample bag with the donor blood.Analysis of the run data file did not indicate any large volumes of air entered through the inlet line.If air was being drawn into the inlet line, the centrifuge pressure signals would be increased from normal levels.However, the centrifuge pressure in this procedure remained within normal levels.Additionally, the run data file showed the lower reservoir sensor was detecting air and fluid appropriately, as evidenced by detecting fluid during priming of the return line and air at the end of each return cycle.All return cycles were shown to have normal reservoir volumes so it is not suspected that the reservoir would have emptied by more than expected, allowing air to enter the line without the system detecting it.Signals from the reservoir appeared perfectly normal, meaning the reservoir seemed to be filling and emptying as expected with no suspected air or foam present.

Event Description

The customer reported that 3cm of air was in the returned bloodline and was sent to the donor.The customer reported that the machine was setup correctly.As a precaution, the donor was sent to a hospital.Donor's health remains well and it is unknown if medical intervention was required for this event.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS, PLT + AUTO PAS, PLS 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: 16701741
• MDR Text Key: 312888569
• Report Number: 1722028-2023-00134
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2023

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: 5823212
• Device Lot Number: 2208294351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 78 KG