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

Model Number 917000000

Device Problems Component Falling (1105); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: a service technician visually inspected the machine at the customer's site andnoted that the caster and iv pole were loose.The machine was taken outof service and replacedwith another trima machine.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the iv pole on the trima equipment falls down unexpectedly.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.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.During customer follow-up, the customer clarified that the iv pole was loose, rotating, and the iv pole did not fall unexpectedly and the iv pole stayed in the 'up' position.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: investigation results indicate that there is no potential for injury to the nature of the iv pole failure and there is no safety issue associated with the reported condition.The root cause of loose, rotating iv pole was due to age and normal wear.

Event Description

No injury was reported for this incident and no patient (donor) was connected at the time of the reported event, therefore no patient (donor) 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: 7220648
• MDR Text Key: 98711110
• Report Number: 1722028-2018-00022
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: BK970005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2018

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: 01/02/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 04/26/2018
• Supplement Dates FDA Received: 04/03/2018; 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/1998
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other