MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA MACHINE,FINAL ASSY, CHINA

Model Number 81011

Device Problems Mechanical Problem (1384); Device Slipped (1584); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service techinician checked out the machine at the customer site and was able to confirm the reported condition that the iv pole could not be locked.It was determined that adjustment/alignment was required.The techinican performed the adjustment/alignment on the button of locking mechanism of the iv pole.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the iv pole on the trima equipment unexpectedly lowers down.The iv pole is reported unable to be locked.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.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, e.3, h.6 and h.10.Corrected information is provided in e.1.Root cause: the root cause of the reported incident was the button of the locking mechanism needed adjustment.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.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 issues related to the reported condition identified.Investigation is in process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA MACHINE,FINAL ASSY, CHINA
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10960472
• MDR Text Key: 220979866
• Report Number: 1722028-2020-00534
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

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: 81011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/15/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 02/05/2021; 03/02/2021
• Supplement Dates FDA Received: 02/12/2021; 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other