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); Insufficient Information (3190)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

The customer reported that the iv pole falls easily.There was not a patient or operator involved at the time the iv pole fell, therefore patient information is not reasonably known.

Manufacturer Narrative

Investigation: the terumo bct service technician inspected the device at the customer site.The technician adjusted the nut of the iv pole and the device was released for use.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in e.1, h.6 and h.10.Investigation: the terumo bct service technician inspected the device at the customer site.The technician adjusted the nut of the iv pole and the device was released for use.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.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the need for an iv pole screw adjustment.

Event Description

The customer reported that the iv pole falls easily.There was not a patient or operator involved at the time the iv pole fell, therefore patient information is not reasonably known.

Event Description

The customer reported that the iv pole falls easily.There was not a patient or operator involved at the time the iv pole fell, therefore patient information is not reasonably known.

Manufacturer Narrative

Investigation: the terumo bct service technician inspected the device at the customer site.The technician adjusted the nut of the iv pole and the device was released for use.The device serial number history report indicates no further related issues have been reported for this device.Investigation is in process.A follow up report will be provided.

• 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: 15509463
• MDR Text Key: 306324334
• Report Number: 1722028-2022-00318
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

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
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 12/16/2022
• Supplement Dates FDA Received: 12/12/2022; 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2012
• 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