CanadaThe SynchroMed Clinician Programmer Application (Medtronic A810) used to program SynchroMed 8637 and 8667 pumps is affected; affected product identifiers include SynchroMed Clinician Programmer Application with lot/serial numbers of more than 10 numbers (contact the manufacturer for specifics). A software sequencing issue with flex dosing can fail to reorder overlapping steps entered out of chronological order, causing infusion steps to be delivered at incorrect times and potentially resulting in missed flex doses, underdosing, or shifts in dose timing with no immediate alerts; other infusion modes are not impacted. Contact the manufacturer for additional information.
What's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: SynchroMed Clinician Programmer Application; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A810
The hazard
Complaint investigations identified a software sequencing issue in the Medtronic A810 SynchroMed Clinician Programmer Application (CP app), specifically affecting flex dosing when programming the SynchroMed 8637 and 8667 pumps. When flex dosing steps are added overlapping and then out of chronological order, the app may fail to reorder them correctly, resulting in infusion steps being delivered at incorrect times. This can lead to missed flex doses, underdosing, or shifts in dose timing, and no immediate alerts. The issue is limited to flex dosing and does not impact other infusion modes. Eleven (11) complaints have been reported globally related to this issue.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)