MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

Model Number 000000000917000000

Device Problems Improper or Incorrect Procedure or Method (2017); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

The customer reported an incident of data input error in the trima system for a platelet donation procedure.The operator entered the donor height and weight as (b)(6) and (b)(6).When the actual donor height and weight is (b)(6) and (b)(6).The error was not discovered until post donation.No medical intervention was necessary for this event.The donor is reported in healthy condition.Patient's (donor's) full identifier: (b)(6).Patient's (donor's) age is not available at this time.

Manufacturer Narrative

Initial reporter email: (b)(6): the fluid used during the procedure was anti-coagulant (acd-a).The customer stated that they could not enter donor's actual information in the trima system and review 'eligible' offered procedures and confirmed the performed procedure was listed.Terumo bct support specialist checked donor eligibility for procedure performed and calculations confirmed that the donor was eligible for the donation with his actual height and weight.Support specialist also reviewed the ac infusion rate to donor using calculation of actual ac volume to donor in the run, compared to donor's maximum ac infusion for 1.2 ml/min.Total ac to donor was 81 ml in 50 minute run = 1.62 ml/min.Donor tbv 5.5 x 1.2 max per minute would allow 6.6 ml per/min, ac infusion less than maximum for the donor.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: terumo bct clinical support received a request to investigate a run data file to determine what may have led to a higher than expected white blood cell content in a platelet procedure.During evaluation of this request clinical support identified that the operator had inaccurately entered the donor height and weight which can lead to potential ac over-infusion or hypovolemia.A one year service history review of this device did not reveal any reports related to the reported condition.A internal report indicates no further related issues have been reported for this device.Additional information: during customer follow-up, real time awareness was provided in regards to the incorrect donor data entry.Root cause: user interface.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4680820
• MDR Text Key: 21932043
• Report Number: 1722028-2015-00134
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK030083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 000000000917000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91