MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SMPLR AUTOPAS, MULTI PLS, RBC

Catalog Number 4824602

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 09/30/2023

Event Type  malfunction  

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 apheresis platelet/plasma procedure on the first return, approximately 2" of air was in return line.The tech tried to divert the air into the draw line, but approximately 1" of air reached the line to the needle.The tech clamped the line and ended run without rinseback before air went into donor.Per the customer all lugers were tight and there was no clotting observed in the channel or return reservoir.Full unit id: (b)(6) patient age and outcome are unknown at this time 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.The run data file (rdf) was analyzed for this event.The run data file was investigated for the procedure on (b)(6) 2023.The operator selected procedure 9, a 7.6e11 platelet yield and 250 ml plasma collection.At 4 minutes, there was one 'return pressure high' alert and the operator paused the procedure, which generated one 'pumps paused' alert.The operator then ended the procedure without rinseback.At the end of the 4 minute procedure, there were no product verification and labelling messages to display.The signals in the run data file indicate that the vacuum pressure in the draw line was disrupted shortly before the 'start draw' button was pressed.This indicates that the blue blood diversion clamp may have been opened prior to the donor being connected to the system, potentially allowing some air to enter the return line.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.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 apheresis platelet/plasma procedure on the first return, approximately 2" of air was in return line.The tech tried to divert the air into the draw line, but approximately 1" of air reached the line to the needle.The tech clamped the line and ended run without rinse back before air went into donor.Per the customer all lugers were tight and there was no clotting observed in the channel or return reservoir.Full unit id: (b)(6) patient age and outcome were not provided by the customer.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 b.5, h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.The run data file was investigated for the procedure on (b)(6) 2023.The operator selected procedure 9, a 7.6e11 platelet yield and 250 ml plasma collection.At 4 minutes, there was one 'return pressure high' alert and the operator paused the procedure, which generated one 'pumps paused' alert.The operator then ended the procedure without rinseback.At the end of the 4 minute procedure, there were no product verification and labelling messages to display.The signals in the run data file indicate that the vacuum pressure in the draw line was disrupted shortly before the 'start draw' button was pressed.This indicates that the blue blood diversion clamp may have been opened prior to the donor being connected to the system, potentially allowing some air to enter the return line.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer history report indicates there were five reports of similar issues dating from january 2022.See mdrs 1722028-2023-00150, 1722028-2023-00340, 1722028-2023-00368, 1722028-2022-00042, 1722028-2022-00159.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: a clamp malfunction where the clamp skews to the side as it is closed.The clamp does not fully occlude the tubing when closed due to interference between the clamp and the tube.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 lower level sensor.A disposable manufacturing defect additional contributing factors could be related to user interface, where the blood diversion clamp was not closed at the system prompt, or the clamp was closed but it was skewed on the tubing enabling a portion of the tubing to allow air to pass.

Event Description

The customer reported to terumo bct customer support that during a apheresis platelet/plasma procedure on the first return, approximately 2" of air was in return line.The tech tried to divert the air into the draw line, but approximately 1" of air reached the line to the needle.The tech clamped the line and ended run without rinseback before air went into donor.Per the customer all luers were tight and there was no clotting observed in the channel or return reservoir.Full unit id: (b)(6) terumo bct clinical support sent three requests for further information from the customer but did not receive any responses.Patient age and outcome were not provided by the customer.The collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SMPLR AUTOPAS, MULTI PLS, RBC
• 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: 17996889
• MDR Text Key: 326397020
• Report Number: 1722028-2023-00350
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824607
• UDI-Public: 05020583824607
• 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: 10/24/2023

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: 4824602
• Device Lot Number: 2212122142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 10/26/2023; 02/21/2024
• Supplement Dates FDA Received: 11/14/2023; 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2022
• 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 Sex: Male