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

Model Number 81000

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

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the iv pole clamp was installed on the device, but was not installed at the time the iv pole was unexpectedly lowering.A terumo bct service technician checked out the machine at the customer site as was able to confirm the reported condition.The technician found that the iv pole was falling with nothing on it.The technician adjusted/aligned the push button/screw on the inside of the panel.The iv pole was successfully tested and returned to service.One year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.Correction: the iv pole clamp was installed on this device on january 2, 2019 per fa 30.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.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

Root cause: the root cause of this failure was the push button/screw on the inside of the panel needed adjustment.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA MACHINE,FINAL ASSY
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10508175
• MDR Text Key: 206170337
• Report Number: 1722028-2020-00433
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• Combination Product (y/n): N
• PMA/PMN Number: BK040069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other