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

Catalog Number 5824102

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

Patient Problem Air Embolism (1697)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The customer reported to terumo bct customer support that during a platelet collection procedure on trima the device alarmed and it was noticed that there was air in the tubing and the procedure was canceled.The leurs were tight and there was no clotting.Per the customer, the donor was not affected.The patient id is unknown at this time.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during a platelet collection procedure on trima the device alarmed and it was noticed that there was air in the tubing and the procedure was canceled.The leurs were tight and there was no clotting.Per the customer, the donor was not affected.The customer declined to provide the patient identifier.The platelet 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.10.Corrected information is provided in b.3.Investigation: the customer submitted five photographs in lieu of the disposable set to aid investigation.One image shows the trima screen and confirms alarm 134 was displayed.Two images show the set loaded in the centrifuge and confirms it is loaded adequately but the upper hex is noted to be not loaded in the hex holder and the upper bearing in not loaded in the bearing holder.The last two images show the cassette loaded on the trima device and confirm the presence of a lot of air in along the return line from the return pump header.The pump header tubing appears to be loaded optimally on all pumps, and no air bubbles are noted in any of the other lines or in the cassette or reservoir.There appears to be some clumping in the inlet filter trap and rbc recirc line to reservoir, but this cannot be completely confirmed from the photographs alone.The valves are noted to be in the closed position.Blood is observed in the left hand side of the cassette, with platelets and plasma noted in their respective tubing on the right hand side of the cassette.No kinks or misassemblies are observed.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed alarm 134, ¿level sensor failure¿ was generated during this procedure.This alarm was generated because the first return cycle took longer than expected to empty the reservoir.Run data file did not show a conclusive root cause for this long return cycle, however, it cannot be ruled out the early access issues contributed to this.Other possible causes for the long return cycle, include, but are not limited to: - occluded or kinked vent bag line - partial obstruction/occlusion on/in the return line tubing - partial occlusion at the venipuncture site - incorrectly loaded tubing set - return pump header loaded incorrectly - defective lower level reservoir sensor or one that requires cleaning - manufacturing defect in the return line, which may be located at the return filter, the pump header bonds, the manifold, etc.Alarm 134 is a shutdown alarm to ensure no air is returned to the donor.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, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during a platelet collection procedure on trima the device alarmed and it was noticed that there was air in the tubing and the procedure was canceled.The leurs were tight and there was no clotting.Per the customer, the donor was not affected.The customer declined to provide the patient identifier.The platelet 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.10.Investigation: the customer submitted five photographs in lieu of the disposable set to aid investigation.One image shows the trima screen and confirms alarm 134 was displayed.Two images show the set loaded in the centrifuge and confirms it is loaded adequately but the upper hex is noted to be not loaded in the hex holder and the upper bearing in not loaded in the bearing holder.The last two images show the cassette loaded on the trima device and confirm the presence of a lot of air in along the return line from the return pump header.The pump header tubing appears to be loaded optimally on all pumps, and no air bubbles are noted in any of the other lines or in the cassette or reservoir.There appears to be some clumping in the inlet filter trap and rbc recirc line to reservoir, but this cannot be completely confirmed from the photographs alone.The valves are noted to be in the closed position.Blood is observed in the left hand side of the cassette, with platelets and plasma noted in their respective tubing on the right hand side of the cassette.No kinks or misassemblies are observed.The run data file (rdf) was analyzed for this event.Run data file analysis confirmed alarm 134, level sensor failure was generated during this procedure.This alarm was generated because the first return cycle took longer than expected to empty the reservoir.Run data file did not show a conclusive root cause for this long return cycle, however, it cannot be ruled out the early access issues contributed to this.Other possible causes for the long return cycle, include, but are not limited to: - occluded or kinked vent bag line - partial obstruction/occlusion on/in the return line tubing - partial occlusion at the venipuncture site - incorrectly loaded tubing set - return pump header loaded incorrectly - defective lower level reservoir sensor or one that requires cleaning - manufacturing defect in the return line, which may be located at the return filter, the pump header bonds, the manifold, etc.Alarm 134 is a shutdown alarm to ensure no air is returned to the donor.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.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for the air in the return line could not be determined but it is likely due to one or a combination of the possible causes listed below: * foam from plasma drain is perceived as fluid by low level sensor resulting in microbubbles in return reservoir returned to donor during plasma flush causing air embolism to donor.* a defective low level sensor.* blood clots causing an obstructed low level sensor or clogged return filter.* full or partial occlusion in lines due to kinks or blockages.* tubing length changes causing insufficient volumes pumped during prime resulting in set not fully primed.Causes for the long return cycle, include, but are not limited to: * donor access issues * occluded or kinked vent bag line * partial obstruction/occlusion on/in the return line tubing * partial occlusion at the venipuncture site * incorrectly loaded tubing set * defective lower level reservoir sensor or one that requires cleaning * manufacturing defect in the return line, which may be located at the return filter, the pump header bonds, the manifold, etc.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMALRS PLATELET PLASMA RBC AUTOPAS 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: 17613564
• MDR Text Key: 322058619
• Report Number: 1722028-2023-00291
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 5020583824102
• Combination Product (y/n): N
• Reporter Country Code: KZ
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2023

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: 5824102
• Device Lot Number: 2210244251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 08/25/2023; 12/13/2023
• Supplement Dates FDA Received: 09/18/2023; 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG