Model Number 81000 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/02/2022 |
Event Type
malfunction
|
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
|
Investigation: a terumo bct service technician checked out the machine at the customer site.The technician verified the iv pole was not staying up even if button was not pressed and there was no resistance.The tech adjusted and tightened the internal screw for iv pole to assure pole will not fall by itself abd confirmed the iv pole only goes down when button is pressed.The device was returned to service.Investigation is in process.A follow-up report will be provided.
|
|
Manufacturer Narrative
|
This report is being filed to provide additional information in h.6 and h.10.Investigation: a terumo bct service technician checked out the machine at the customer site.The technician verified the iv pole was not staying up even if button was not pressed and there was no resistance.The tech adjusted and tightened the internal screw for iv pole to assure pole will not fall by itself and confirmed the iv pole only goes down when button is pressed.The device 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.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be a loose screw.
|
|
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.
|
|
Search Alerts/Recalls
|