Model Number 8120 |
Device Problems
Pumping Stopped (1503); Insufficient Information (3190)
|
Patient Problem
Pain (1994)
|
Event Date 11/08/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Device was not returned to manufacturing facility.
|
|
Event Description
|
A report was received from health canada's canada vigilance program which states, "pt was transferred from par just prior to evening shift change.Patient yelling out in pain, writer noticed that ketamine infusion channel was turned off but full ketamine syringe was inside chamber.Charge rn notified and verified as well.Total volume infused was zero.Charge rn and writer started ketamine infusion as per orders at 10mg/hr.".
|
|
Manufacturer Narrative
|
Additional information : imdrf annex a code.
|
|
Event Description
|
A report was received from health canada's canada vigilance program which states, "pt was transferred from par just prior to evening shift change.Patient yelling out in pain, writer noticed that ketamine infusion channel was turned off but full ketamine syringe was inside chamber.Charge rn notified and verified as well.Total volume infused was zero.Charge rn and writer started ketamine infusion as per orders at 10mg/hr.".
|
|
Search Alerts/Recalls
|