MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT + SAMPLER, MULTIPLS, RBC

Model Number	82416
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: calculations to determine if ac over-infusion occurred based on infusion rate: ac to donor 489ml 85 minute procedure actual tbv 5602ml 489 ml ac/85 min/5.602 l tbv = 1.03 ml ac/min/ l tbv.The procedure did not go over the limit of 1.2 ml ac/min/ l tbv.Amount of product collected: 463.1 ml 463.1/5602 = 8.3% of tbv the run data file was analyzed for this event.Investigation of the run data file showed that trima operated as intended during this collection.The operator selected the 6th procedure on the priority list.There were no alerts during the collection and at the end of the procedure the screen displayed the message: 'platelet product: label as leukoreduced.' the device history record was reviewed for this lot.There were no issues noted that would have contributed to the ac over infusion as experienced by the customer.Quality labs passed and sterilization requirements passed.Correction: this customer was aware of the mistake and reported the issue.This customer site has not called with any further issues with any procedure after this.No retraining was required.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer called to report that they had a data entry error.The operator inadvertently entered the donors height as 6'9" for a double platelet donation.The donors actual height is 5'9".The error was caught during record review at the end of the day.The donor did not have any adverse events and was released to home post donation.The patient outcome was listed as stable and healthy full patient id: (b)(6) the collection set is not available for return for evaluation because it was discarded by the customer.
Event or Problem Description
The customer called to report that they had a data entry error.The operator inadvertently entered the donors height as 6'9" for a double platelet donation.The donors actual height is 5'9".The error was caught during record review at the end of the day.The donor did not have any adverse events and was released to home post donation.The patient outcome was listed as stable and healthy full patient id: (b)(6).The collection set is not available for return for evaluation 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: calculations to determine if ac over-infusion occurred based on infusion rate: ac to donor 489ml 85 minute procedure actual tbv 5602ml 489 ml ac/85 min/5.602 l tbv = 1.03 ml ac/min/ l tbv.The procedure did not go over the limit of 1.2 ml ac/min/ l tbv.Amount of product collected: 463.1 ml 463.1/5602 = 8.3% of tbv the run data file was analyzed for this event.Investigation of the run data file showed that trima operated as intended during this collection.The operator selected the 6th procedure on the priority list.There were no alerts during the collection and at the end of the procedure the screen displayed the message: 'platelet product: label as leukoreduced.' the device history record was reviewed for this lot.There were no issues noted that would have contributed to the ac over infusion as experienced by the customer.Quality labs passed and sterilization requirements passed.Correction: this customer was aware of the mistake and reported the issue.This customer site has not called with any further issues with any procedure after this.No retraining was required.Root cause: the root cause of the possible ac over infusion was determined to be due to an operator error where they entered the incorrect donor height in the system.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT + SAMPLER, MULTIPLS, 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: 16102400
• Report Number: 1722028-2023-00004
• Device Sequence Number: 7636835
• Product Code: GKT
• UDI-Device Identifier: 05020583824164
• UDI-Public: 05020583824164
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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 Expiration Date: 09/01/2024
• Device Model Number: 82416
• Device Catalogue Number: 4824162
• Device Lot Number: 2209102142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2022
• 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 Age: 37 YR
• Patient Sex: Male