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

Model Number 917000000

Device Problems Component Falling (1105); Unintended System Motion (1430)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician visually inspected the machine at the customer's site and found that centrifuge door was damaged and iv pole button screw was out of position.The centrifuge door was replaced and the iv pole button screw was adjusted.The service technician verified the iv pole is functioning properly.The machine was returned to service.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a procedure, the iv pole on the trima equipment unexpectedly lowers down.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: an internal report shows that the machine has been in use with no further occurrences of the problem.One year of service history was reviewed for this device with no other problems identified related to the reported condition.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.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.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.The root cause of the slipping iv pole was the push button screw had loosened out of position, allowing the iv pole to slip.

• 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: 6965303
• MDR Text Key: 90161173
• Report Number: 1722028-2017-00405
• 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
• Report Date: 10/20/2017

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: 917000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 11/09/2017; 11/14/2017
• Supplement Dates FDA Received: 11/14/2017; 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other