MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA MACHINE, FINAL ASSY

Model Number 81000

Device Problems Mechanical Problem (1384); Device Slipped (1584); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site.It was found that the iv pole was not holding in place and kept slipping down.The technician bent the mechanical lever back into place, and the pole button was realigned so it hits the mechanical lever correctly.The iv pole was confirmed working accordingly.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: the iv pole clamp was installed on this device per fa 30 on (b)(6) 2019.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that the iv pole on the trima equipment unexpectedly lowers down.Per the customer, the iv pole clamp was installed on the device.No injury was reported for this incident and no patient was connected at the time the iv pole was sliding down, therefore no patient information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: the root cause of this failure was the mechanical lever was bent and the release button was misaligned.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA MACHINE, FINAL ASSY
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10494844
• MDR Text Key: 206189341
• Report Number: 1722028-2020-00425
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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: 81000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other