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

Model Number 917000000

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service representative checked out that machine at the customer site for preventative maintenance (pm).During the pm, it was discovered that the iv pole wold drop with slight pressure due to a defective or worn iv pole locking mechanism.The service representative confirmed the iv pole clamp was installed on this device.The iv pole clamp had been installed (b)(6) 2020 per field action 30.On (b)(6) 2020, service returned to customer site and replaced the iv pole and locking mechanism in accordance with manufacturer's procedures.Normal operation of the iv pole was verified prior to placing the machine back in service.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 issues related to the reported condition identified.Root cause: the root cause of this failure was a worn iv pole locking mechanism.

Event Description

During routine preventive maintenance of the device, it was discovered that the iv pole would drop with slight pressure.No donor or operator involvement was reported for this specific incident and ther was no injury reported, therefore there is no patient information 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: scot hilden ; 10810 w collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10356355
• MDR Text Key: 201915905
• Report Number: 1722028-2020-00358
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2020

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: 07/15/2020
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2004
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other