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

Model Number 81000

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

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the iv pole clamp was installed on this device.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.Correction: it was confirmed 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.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 h6 and h10.Investigation: a terumo bct service technician checked out the machine at the customer site.Upon evaluation, it was found that the iv pole would not stay up in any position.It was determined that the screw on the left side panel was pushing in on the lever that adjusts the iv pole.The screw was adjusted to allow the lever that adjusts the iv pole to not push in on the iv pole.Root cause:the root cause of this failure was the screw on the left side panel needed to be adjusted.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA MACHINE,FINAL ASSY
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10755971
• MDR Text Key: 215985363
• Report Number: 1722028-2020-00487
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583810006
• UDI-Public: 05020583810006
• Combination Product (y/n): N
• PMA/PMN Number: BK150321
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

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: 10/07/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other