Recall MonitorHealth Products
SynchroMed Clinician Programmer Application
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: SynchroMed Clinician Programmer Application
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| SynchroMed Clinician Programmer Application | More than 10 numbers, contact manufacturer. | A810 |
Issue
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.