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

Catalog Number 4824062

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Air Embolism (1697); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2023

Event Type  malfunction  

Event Description

A customer reported to terumo bct customer support that a patient received air during a apheresis platelet procedure.The customer reported that the initial stick was slow and had high return pressure and they called over a colleague to assist.After the adjustment they watched the return and suddenly noticed air in the line returning to the donor.The customer clamped the line returning to the donor and then an alarm 124 -"level sensor failure" appeared and the run was ended.They customer clamped the line as soon as they saw it, but are unaware how much air the donor received.The customer reported that the donor did not appear to be in any distress and there were no complaints of any effects.Full patient id- (b)(6) patient gender is not available from the customer.The donor left in stable condition and the customer contacted them later in the day to check in and the donor stated they were fine.The luer connections were tight and there was no signs of clotting in the channel or reservoir.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Based on the available information, the presence of air in the return line was likely the result of an issue with the specific tubing set used for this procedure.It is suspected, though cannot be confirmed, that excess solvent was used to bond the reservoir-side of the return pump header, eventually developing a leak path that allowed air to be drawn into the return line during the first return cycle.The signals in the run data file indicate no issues with the priming of the return line.There were no access interruptions during the priming of the return line, and the volume pumped by the return pump during this portion of procedure falls within the expected range.The transition from air to fluid occurred as expected at both the low-level sensor and the high-level sensor during the first draw cycle.Therefore, it is not suspected that air was introduced into the return line until sometime during the first return cycle.Based on the available information, the 'level sensor error' alarm that ended the procedure, as well as some of the 'return pressure too high' alerts, were likely the result of the operator clamping the donor access line shut after observing air present in the return line.This alarm indicated that the volume in the reservoir did not empty to the lower reservoir sensor as expected.It's also possible, though not conclusive, this alarm occurred because the air being drawn into the return line prevented the movement of fluid through the reservoir as expected." 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.Terumo bct communicated with stanford staff to discuss the failure mode, and answer questions regarding the report.Explained the proposed failure mechanism of solvent over-bonding on the reservoir side of the return pump header, and how this could lead to a leak that develops gradually over the course of the procedure, rather than being apparent immediately, or being detected during the tubing set test.Explained the various mitigations in place for this type of failure and communicated that this was the only reported failure of this mode on this lot.The customer submitted four photographs in lieu of the disposable set to aid investigation.Three of the photos show the set loaded on a trima device and blood is observed throughout the set.The ac bag is noted to be approx.90% full with fluid in the drip chamber.The return reservoir is noted to be approx.Half full.A lot of air is confirmed to be present in both the ac and return lines from the cassette to the manifold.An air bubble is observed in the ac line too.The forth photograph shows a close up of the inlet coil.The white clamp on the diversion bag line and the blue pinch clamp on the donor line are both in the closed position.A pair of metal hemostats have been set on top of the channel lines to cassette.All pump header tubing is loaded correctly.Investigation is in process, a follow-up report will be provided.

Event Description

A customer reported to terumo bct customer support that a patient received air during a apheresis platelet procedure.The customer reported that the initial stick was slow and had high return pressure and they called over a colleague to assist.After the adjustment they watched the return and suddenly noticed air in the line returning to the donor.The customer clamped the line returning to the donor and then an alarm 124 -"level sensor failure" appeared and the run was ended.They customer clamped the line as soon as they saw it, but are unaware how much air the donor received.The customer reported that the donor did not appear to be in any distress and there were no complaints of any effects.Full patient id- (b)(6) patient gender is not available from the customer.The donor left in stable condition and the customer contacted them later in the day to check in and the donor stated they were fine.The luer connections were tight and there was no signs of clotting in the channel or reservoir.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.Based on the available information, the presence of air in the return line was likely the result of an issue with the specific tubing set used for this procedure.It is suspected, though cannot be confirmed, that excess solvent was used to bond the reservoir-side of the return pump header, eventually developing a leak path that allowed air to be drawn into the return line during the first return cycle.The signals in the run data file indicate no issues with the priming of the return line.There were no access interruptions during the priming of the return line, and the volume pumped by the return pump during this portion of procedure falls within the expected range.The transition from air to fluid occurred as expected at both the low-level sensor and the high-level sensor during the first draw cycle.Therefore, it is not suspected that air was introduced into the return line until sometime during the first return cycle.Based on the available information, the 'level sensor error' alarm that ended the procedure, as well as some of the 'return pressure too high' alerts, were likely the result of the operator clamping the donor access line shut after observing air present in the return line.This alarm indicated that the volume in the reservoir did not empty to the lower reservoir sensor as expected.It's also possible, though not conclusive, this alarm occurred because the air being drawn into the return line prevented the movement of fluid through the reservoir as expected." 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.Terumo bct communicated with stanford staff to discuss the failure mode, and answer questions regarding the report.Explained the proposed failure mechanism of solvent over-bonding on the reservoir side of the return pump header, and how this could lead to a leak that develops gradually over the course of the procedure, rather than being apparent immediately, or being detected during the tubing set test.Explained the various mitigations in place for this type of failure and communicated that this was the only reported failure of this mode on this lot.The customer submitted four photographs in lieu of the disposable set to aid investigation.Three of the photos show the set loaded on a trima device and blood is observed throughout the set.The ac bag is noted to be approx.90% full with fluid in the drip chamber.The return reservoir is noted to be approx.Half full.A lot of air is confirmed to be present in both the ac and return lines from the cassette to the manifold.An air bubble is observed in the ac line too.The forth photograph shows a close up of the inlet coil.The white clamp on the diversion bag line and the blue pinch clamp on the donor line are both in the closed position.A pair of metal hemostats have been set on top of the channel lines to cassette.All pump header tubing is loaded correctly.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: excess solvent was used to bond the reservoir-side of the return pump header, eventually developing a leak path that allowed air to be drawn into the return line during the first return cycle.Tubing length changes, algorithm error, full occlusion of the line due to kink or other blockages.Line of the sample pouch on the donor line not fully closed prior pressing start button.

• 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: 18211955
• MDR Text Key: 330432871
• Report Number: 1722028-2023-00394
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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: 4824062
• Device Lot Number: 2305032142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2023
• 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: 52 YR