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

Model Number 81000

Device Problems Mechanical Problem (1384); Device Slipped (1584)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

The customer reported that the iv pole on the trima equipment unexpectedly lowers down.The customer was using pre-wrap tape to prevent the iv pole from falling.No adverse event occurred and no medical intervention was required.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

Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The technician found that the iv pole button screw was initiating iv pole release prematurely.The screw was replaced and adjusted per manufacturers procedures.An auto test was performed with no issues.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.Correction: a field service engineer adjusted the iv pole button.Root cause: a root cause assessment was performed for this complaint.The root cause of the iv pole issue was determined to be related the need for an iv pole button adjustment.Based on the available information a definitive root cause for the sound issue could not be determined.This report was filed beyond the 30 day timeframe due to an internal processing error.An internal nonconformance has been initiated to address the issue.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 18547367
• MDR Text Key: 333547552
• Report Number: 1722028-2024-00027
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other