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

Model Number 81000

Device Problems Component Falling (1105); Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a service call was placed and a terumo bct service technician visually inspected the machine at the customer's site.The service technician was able to duplicate the reported condition.Upon visual inspection, the technician found that when the side of the machine where the release button is for the iv pole is pressed, the pole lowers unexpectedly.It was noted that the button bolt was making contact with the pole mechanism causing any slight movement to activate the lock.The iv pole was cleaned with alcohol to remove debris and the pole release button was aligned.The machine was returned to service.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the iv pole on the trima machine would not stay up.Per the customer, no injuries occurred to the operators or donors for this incident.No injury was reported for this incident and no patient (donor) was connected at the time the iv pole was sliding down, therefore no patient (donor) information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: 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 other problems identified related to the reported condition.Root cause: the root cause of this failure was a misaligned iv pole release button.Correction: a trima field action 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.

• 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: 7276542
• MDR Text Key: 100527656
• Report Number: 1722028-2018-00041
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040069
• 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: 02/16/2018

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: 01/22/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other