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

Model Number 917000000

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a service technician visually inspected the machine at the customer's site and was able to duplicate the reported condition.The technician found that the release mechanism of iv pole needed adjusted.The technician adjusted and successfully tested the release mechanism of the iv pole and 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 dropped unexpectedly during prime.No injury was reported for this incident and no patient (donor) was connected at the time the iv pole was dropping down unexpectedly.Therefore, no patient information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: the root cause of this failure was the push button screw had loosened out of position allowing the iv pole to slip.

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.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 still in process.A follow-up report will be provided.

• 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: 7293315
• MDR Text Key: 101136834
• Report Number: 1722028-2018-00050
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK010006
• 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,Followup
• Report Date: 02/23/2018

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: 917000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 04/06/2018; 05/08/2018
• Supplement Dates FDA Received: 04/13/2018; 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other