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

Model Number 81012

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

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at the customer site and found that the iv pole easily fell down.The technician adjusted the press button and the machine was returned to 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 other problems identified related to the reported condition.Correction: trima field action 30 has been initiated to notify all trima users to use precaution while transporting the device and a caution statement was included in the operator's manual.It was confirmed by the customer that the iv pole clamp was installed on this device at the time of the incident.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.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 and no medical intervention was required.

Event Description

This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6, and h.10.The 510k provided in the intial mdr is not relevent to this case.Root cause: the root cause of this failure was a misalignment of the release button.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA MACHINE,FINAL ASSY, JAPAN
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9943936
• MDR Text Key: 188113381
• Report Number: 1722028-2020-00156
• Device Sequence Number: 1
• Product Code: GKT
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other