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

Model Number 81000

Device Problems Use of Device Problem (1670); Inadequate User Interface (2958); Patient Data Problem (3197)

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

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an incident of data input error in the vista software system.The operator who performed the procedure had entered the donor's height as (b)(6) instead of the donor's actual height as (b)(6).The vista software system calculated the total blood volume (tbv) with the incorrect height as 6573ml instead of the donor's actual total blood volume of 5456ml.No medical intervention was necessary for the event.The input error was not discovered until post donation procedure.Patient's (donor) full identifier: (b)(6).

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause of this failure is the customer selected the wrong donor in vista.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no other problems identified related to the reported condition.Investigation is still in process.A follow-up report will be filed.

• 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: 7220454
• MDR Text Key: 98635079
• Report Number: 1722028-2018-00020
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040069
• 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: 01/25/2018

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
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 03/28/2018; 04/23/2018
• Supplement Dates FDA Received: 03/30/2018; 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2005
• 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: 00064 YR
• Patient Weight: 89