Model Number 81000 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584); Unintended Movement (3026)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/05/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The bearing sleeve was replaced and the iv pole clamp was installed.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.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Implementation of the addition of a collar for the currently field installed devices will be completed to address this issue.Investigation is still 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.Root cause: the root cause of this failure was a worn iv pole bearing sleeve.
|
|
Search Alerts/Recalls
|