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

Model Number 917000000

Device Problems Component Falling (1105); Positioning Problem (3009)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician visually inspected the machine at the customer's site.The technician found issues with the iv pole movement.The iv pole mechanism was adjusted.An auto test and saline run was successfully completed.A preventive maintenance (pm) was also performed per manufacturer's specification.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.Information of patient (donor) or operator of the device is not known at this time.Outcome of patient (donor) or operator of the device is not known at this time.

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 problems identified related to the reported condition.Root cause: since the adjustment of the button and screw has resolved the issue, it is likely that these parts were defective or a contributing factor.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 not locking in place.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

No injury was reported for this incident and no patient was connected at the time the iv pole was falling down unexpectedly.Therefore, no patient information is reasonably known.

• 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: 6732410
• MDR Text Key: 80811407
• Report Number: 1722028-2017-00300
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK010046
• 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: 07/21/2017

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: 06/29/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/09/2017; 09/05/2017
• Supplement Dates FDA Received: 08/11/2017; 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other