MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT + SAMPLER, PLASMA, AUTOR

Model Number 82616

Device Problems Use of Device Problem (1670); Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: run parameters: donor gender female entered as male 5'2" 180# tbv was 4665 when entered as male procedure selected was a 7.7 platelet with a duration of 86 minutes the platelet collect volume was 515 ac volume was 462 blood volume processed (b)(4) post platelet count 150,000 donor gender if entered correctly as female 5'2" 180# tbv was (b)(4) procedure selected was a 7.7 platelet with a duration of 98 minutes the platelet volume collect volume was 515 ac volume was 470 blood volume processed (b)(4) post platelet count 138,000 using the donor's true tbv, the amount of ac that was returned and the length of the procedure, the average ac infusion rate limit did not exceed the maximum value during this procedure.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the gender was entered into trima incorrectly.The donor was a female and male was selected in error.The donor completed the procedure without any known problems.Patient (donor) identifier and age are not available 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 in h.6 and h.10.Investigation: run parameters: donor gender female entered as male 5'2" ,180lbs.Tbv was 4665 when entered as male, procedure selected was a 7.7 platelet with a duration of 86 minutes the platelet collect volume was 515 ac volume was 462 blood volume processed 5269 post platelet count 150,000.Donor gender if entered correctly as female 5'2", 180 lbs, tbv was 4275, procedure selected was a 7.7 platelet with a duration of 98 minutes the platelet volume collect volume was 515 ac volume was 470 blood volume processed 5362 post platelet count 138,000 using the donor's true tbv.The amount of ac that was returned and the length of the procedure, the average ac infusion rate limit did not exceed the maximum value during this procedure.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 that the gender was entered into trima incorrectly.The donor was a female and male was selected in error.The donor completed the procedure without any known problems.Full patient id: (b)(6) 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 a.1, a.2, b.5 and h.6.Investigation: run parameters: donor gender female entered as male 5'2" 180# tbv was 4665 when entered as male procedure selected was a 7.7 platelet with a duration of 86 minutes the platelet collect volume was (b)(4) ac volume was (b)(4) blood volume processed (b)(4) post platelet count (b)(4) donor gender if entered correctly as female 5'2" 180# tbv was 4275 procedure selected was a 7.7 platelet with a duration of 98 minutes the platelet volume collect volume was (b)(4) ac volume was (b)(4) blood volume processed (b)(4) post platelet count (b)(4) using the donor's true tbv, the amount of ac that was returned and the length of the procedure, the average ac infusion rate limit did not exceed the maximum value during this procedure.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the gender was entered into trima incorrectly.The donor was a female and male was selected in error.The donor completed the procedure without any known problems.Full patient id: (b)(6) the collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: run parameters: donor gender female entered as male 5'2" 180# tbv was 4665 when entered as male procedure selected was a 7.7 platelet with a duration of 86 minutes the platelet collect volume was 515 ac volume was 462 blood volume processed 5269 post platelet count (b)(4) donor gender if entered correctly as female 5'2" 180# tbv was 4275 procedure selected was a 7.7 platelet with a duration of 98 minutes the platelet volume collect volume was 515 ac volume was 470 blood volume processed 5362 post platelet count (b)(4) using the donor's true tbv, the amount of ac that was returned and the length of the procedure, the average ac infusion rate limit did not exceed the maximum value during this procedure.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: clinical support communicated the following to the customer that using the donor's true tbv, the amount of ac that was returned and the length of the procedure, the average ac infusion rate limit did not exceed the maximum value during this procedure.The exact ac infusion rate was 1.17 ml/min/l tbv.Clinical support explained to the customer that a couple of situations could occur if the wrong information is entered: * the ac infusion rate may be too high ¿ causing an ac reaction.* volume of product collected may exceed what is safe for the donor to give tbct clinical support performed retraining by explaining the effect of entering the incorrect information.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 gender in the system.

Event Description

The customer reported that the gender was entered into trima incorrectly.The donor was a female and male was selected in error.The donor completed the procedure without any known problems.Full patient id: (b)(4) the collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT + SAMPLER, PLASMA, AUTOR
• 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: 14877296
• MDR Text Key: 303705319
• Report Number: 1722028-2022-00215
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583826168
• UDI-Public: 05020583826168
• 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,Followup
• Report Date: 06/30/2022

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 Expiration Date: 05/01/2024
• Device Model Number: 82616
• Device Catalogue Number: 3826162
• Device Lot Number: 2205111132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 10/11/2022; 11/28/2022; 03/08/2023
• Supplement Dates FDA Received: 10/29/2022; 12/16/2022; 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2022
• 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: 62 YR
• Patient Sex: Female