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

Model Number 81000

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Device Slipped (1584); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 12/30/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the operator, the iv pole on the trima machine was very sensitive, but the iv pole had not dropped down prior to this incident.The terumo bct service technician inspected the iv pole locking system and shortened the length of the screw to connect to the button and lessen the sensitivity of the button.A preventative maintenance was performed per manufacturer's specifications and the machine was returned to service.The device serial number history report indicates no further related issues have been reported forth is device.One year of service history was reviewed for this device with no issues related to the reported condition identified.Correction: trima field action 30 has been initiated to notify all trima users to use precaution while transporting the device and a caution statement was included in the operator's manual.The iv pole collar has now been installed for this machine.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Investigation is in process.A follow up report will be provided.

Event Description

During a service call at a the customer site, a terumo bct service technician discovered that the iv pole on the trima equipment drops down when machine moves.No injury was reported for this incident and no patient was connected at the time the iv pole was sliding down, therefore no patient information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause of this failure was a loose locking mechanism on the iv pole.

• 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: 8275903
• MDR Text Key: 134880710
• Report Number: 1722028-2019-00022
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: BK110051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other