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

Model Number 81000

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct technician checked out the machine at the customer site and was able to duplicate the reported condition.The technician inspected the trima device and noted that the side panel button was making contact with the iv pole locking lever.The technician adjusted the run out on the iv pole side panel release button and 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 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.Information 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 side panel button has resolved the issue, it is likely that this part was 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 dropping down suddenly.

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 west collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6767138
• MDR Text Key: 82067308
• Report Number: 1722028-2017-00313
• 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: 08/04/2017

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: 07/11/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other