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

Model Number 917000000

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

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: during the preventative maintenance (pm) visit to the customer site, the terumo bct service technician found that the iv pole will not stay up on its own even with all panels removed.The machine did not have the iv pole clamp installed at the time of the event.The device was removed from service as a result of frame damage unrelated to the iv pole falling.The device serial number history report indicates no further related issues have been reported for this device.This device has been removed from service.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.Per service history review and service representative statements, the iv pole clamp had not been installed on this device.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Implementation of the addition of a collar for the currently field installed devices will be completed to address this issue.Investigation is in process.A follow-up report will be provided.

Event Description

During a service call at the customer¿s site, a terumo bct service technician discovered the iv pole on the trima equipment would not stay up.No injury of any kind was reported by the customer.Therefore no patient information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause of the confirmed damage to the device frame and the iv pole was undetermined.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8617955
• MDR Text Key: 146413389
• Report Number: 1722028-2019-00116
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK010046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

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: 917000000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other