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

Model Number	82520
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigaation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during an apheresis double red blood cell procedure an air bubble smaller than a pea was delivered to the donor after a new needle was sterile connected to the draw line.They did prime the line with 3ml of blood per the operator's manual.The donor observed the air bubble and questioned if it was safe and why it happened.Terumo bct customer support informed the customer that a small amount of air is ok because the bubble will dissipate as it enters the blood stream.Patient age was not provided by customer.Full patient id: (b)(6).Patient is in stable condition and was released to self, no complications.The collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that during an apheresis double red blood cell procedure an air bubble smaller than a pea was delivered to the donor after a new needle was sterile connected to the draw line.They did prime the line with 3ml of blood per the operator's manual.The donor observed the air bubble and questioned if it was safe and why it happened.Terumo bct customer support informed the customer that a small amount of air is ok because the bubble will dissipate as it enters the blood stream.Patient age was not provided by customer.Full patient id: (b)(4).Patient is in stable condition and was released to self, no complications.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The customer history report indicates no further related issues have been reported for this customer.The air was at the new needle sterile weld connection.No clotting was noted in the set and there were no alarms.The signals in the run data file indicate the trima accel system operated as intended.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during an apheresis double red blood cell procedure an air bubble smaller than a pea was delivered to the donor after a new needle was sterile connected to the draw line.They did prime the line with 3ml of blood per the operator's manual.The donor observed the air bubble and questioned if it was safe and why it happened.Terumo bct customer support informed the customer that a small amount of air is ok because the bubble will dissipate as it enters the blood stream.Patient age was not provided by customer.Full patient id: (b)(6) patient is in stable condition and was released to self, no complications.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.The customer history report indicates no further related issues have been reported for this customer.The air was at the new needle sterile weld connection.No clotting was noted in the set and there were no alarms.The signals in the run data file indicate the trima accel system operated as intended.Root cause: a root cause assessment was performed for this complaint.Based on the available information, it cannot be ruled out that the air was introduced during the process of sterile welding the new needle to the kit.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL AUTORBC, PLASMA 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: 17365099
• Report Number: 1722028-2023-00249
• Device Sequence Number: 12281881
• Product Code: GKT
• UDI-Device Identifier: 05020583825208
• UDI-Public: 05020583825208
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: 82520
• Device Catalogue Number: 82520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 08/11/2023; 11/10/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/14/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male