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); Positioning Problem (3009)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: service engineer was dispatched for repair.The service engineer found screw for iv pole button needed adjustment.The service engineer adjusted the screw and verified iv pole operates properly.Performed and passed complete autotest.No other functional or safety issues found.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported the iv pole will not stay up.The iv pole guard is in place.There was not a patient or operator involved at the time the iv pole would not stay up, therefore, patient information is not reasonably known.

Manufacturer Narrative

Investigation: service engineer was dispatched for repair.The service engineer found screw for iv pole button needed adjustment.The service engineer adjusted the screw and verified iv pole operates properly.Performed and passed complete autotest.No other functional or safety issues found.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 a loose screw.

Event Description

The customer reported the iv pole will not stay up.The iv pole guard is in place.There was not a patient or operator involved at the time the iv pole would not stay up, therefore, patient information is not reasonably known.

• 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: 14948530
• MDR Text Key: 304350710
• Report Number: 1722028-2022-00222
• 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,Followup
• Report Date: 07/07/2022

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: 06/13/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2018
• 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