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

Model Number 81000

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate User Interface (2958)

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

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the operator entered the donor's actual height information on another trima machine and confirmed that the donor was eligible for the collection procedure with his actual height.A terumo bct's systems engineer performed a calculation on the approximate anti-coagulant(ac) infusion rate and determined that although the height of the donor was incorrectly entered,the donor did not experience ac overinfusion or hypovolemia.It was calculated that the donor had less than 15% tbv removed during the procedure and the donor's ac infusion rate was lower than the maximum for the specified procedure time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an incident of data input error in the trima machine for a collection procedure.The operator entered the donor's height as (b)(6) instead of (b)(6).Per the medical director, the collection procedure was continued.No medical intervention was required for this event.The customer stated that the donor is 'fine' and no adverse events occurred.Patient (donor) identifier and age are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Based on the calculation done by a terumo bct's systems engineer, the donor did not experience hypovolemia or a cover infusion.It was calculated that the donor had less than 15% tbv removed during the procedure and the donor's ac infusion rate was lower than the maximum for the specified procedure time.One year of service history was reviewed for this device with no similar issues to the reported condition identified.Root cause: user interface issue.

Manufacturer Narrative

This report is being filed to provide additional information.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6593485
• MDR Text Key: 76154961
• Report Number: 1722028-2017-00191
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2017

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 Model Number: 81000
• Other Device ID Number: 05020583810006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 07/27/2017; 08/07/2017
• Supplement Dates FDA Received: 07/28/2017; 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• 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 Age: 64 YR
• Patient Weight: 78