Model Number 3810002 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584); Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/28/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation: the device serial number history report indicates no further related issues has been reported for this device.One year of service history was reviewed for this device with no further issues related to the reported condition identified.Correction: a field service engineer adjusted the iv pole push button.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 adverse event occurred and no medical intervention was required.Iv pole clamp was not installed.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
|
Investigation: a terumo bct service engineer checked out the machine at the customer site and was able to confirm the reported problem.The engineer found that the button adjustment was too far out, and shorten the length of the adjustable screw and tested it, iv pole was working properly.The device serial number history report indicates no further related issues has been reported for this device.One year of service history was reviewed for this device with no further issues related to the reported condition identified.Correction: a field service engineer adjusted the iv pole push button.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the need for an adjustment of the iv pole locking screw.
|
|
Event Description
|
The customer reported that the iv pole on the trima equipment unexpectedly lowers down.No adverse event occurred and no medical intervention was required.Iv pole clamp was installed.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.
|
|
Search Alerts/Recalls
|