Model Number 81000 |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384); Device Slipped (1584)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/19/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation: a terumo bct technician adjusted the iv pole on the device at the customer site.Investigation is in process, a follow up report will be provided.
|
|
Event Description
|
The customer reported that the iv pole falls easily.There was not a patient or operator involved at the time of the iv pole falling, therefore no patient information is reasonably known at the time of the event.
|
|
Event Description
|
The customer reported that the iv pole falls easily.There was not a patient or operator involved at the time of the iv pole falling, therefore no patient information is reasonably known at the time of the event.
|
|
Manufacturer Narrative
|
This report is being filed to provide additional information in e.1, h.6 and h.10.Investigation: a terumo bct technician adjusted the iv pole on the device at the customer site.Service was able to confirm the iv pole safety collar was present prior to the reported incident.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 related an adjustment of the iv pole button.
|
|
Search Alerts/Recalls
|