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

Model Number 917000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct technician checked out the machine involved in this event.The iv pole was inspected and was found to be working as expected.A cause for the pole to drop down unexpectedly could not be identified.Installation of software and a preventive maintenance(pm) was also conducted.The machine performed per manufacturing specifications.No further issues have been reported for this device.One year of service history was reviewed for this device with no problems identified related to the reported condition.Root cause: no cause could be identified during machine checkout or review of machine records.The root cause for the iv pole failure was undetermined.

Event Description

The customer reported that when the nurse was pressing the button to lower the iv pole inorder to move the equipment, the pole fell down onto her forefinger, causing a fracture of the distal phalanx on the left hand.Details of the operator's treatment are not available at this time.Patient's (operator) age and weight are not available at this time.

Manufacturer Narrative

Additional information: terumo bct's medical review determined that no malfunction or operator error occurred during this event.However, there is an indication that the trima iv pole dropping on the nurse's finger after she pressed the iv pole release button contributed to the injury causing a fracture on the operator's forefinger.

Manufacturer Narrative

Investigation: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.

Event Description

The customer stated that the operator received surgery on (b)(6) 2016.

Manufacturer Narrative

This report is being filed to provide additional information.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.

Event Description

The customer stated that the operator returned to work and she is 'okay'.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIM ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5890219
• MDR Text Key: 52567754
• Report Number: 1722028-2016-00463
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: BK010006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 917000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00037 YR
• Patient Weight: 62