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

Model Number 81000

Device Problems Device Operational Issue (2914); Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Serial number is not available at this time.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.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Investigation is in process.A follow up report will be provided.

Event Description

Customer stated that as the operator started moving the trima machine, the iv pole dropped unexpectedly.The pole dropped onto her thumb, causing a small laceration.The operator did not require any medical intervention or follow up.She placed a small adhesive bandage on her thumb and continued to work.Current operator outcome is healthy.

Manufacturer Narrative

The customer did not provide a serial number pertaining to this event, therefore, a service history review could not be conducted for this specific incident.All equipment must meet acceptance criteria before release.An internal report indicates no further related issues have been reported for this customer.Root cause: the root cause is the free falling of the trima iv pole if the customer does not hold onto the iv pole when the iv button is pressed.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6358085
• MDR Text Key: 68605871
• Report Number: 1722028-2017-00049
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

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
• Other Device ID Number: 05020583810006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00034 YR
• Patient Weight: 91