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

Model Number 81000

Device Problems Component Falling (1105); Fail-Safe Design Failure (1222); Device Operational Issue (2914)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

Serial number is not available at this time.Investigation: during customer follow-up, the customer stated that the injury was due to operator error and there are no indication that an equipment malfunction caused the injury.The incident was reported to workman's comp.Investigation is in process.A follow-up report will be provided.

Event Description

Upon review of the terumo bct's medical device safety alert form, the customer reported that while the operator was lowering the iv pole on the trima machine, the pole fell down onto her thumb, causing a non-displacement fracture.Patient information and outcome are not available at this time.The customer declined to provide further details about the reported incident.

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 device.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.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.

Event Description

The customer declined to provide patient (operator) information and outcome.

• 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: 6357606
• MDR Text Key: 68604421
• Report Number: 1722028-2017-00046
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162365
• 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: 02/01/2017
• 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