On March 5, the FDA posted an alert for 85,961 Medfusion Model 3500 Syringe Infusion Pumps, and two weeks earlier, the agency published a warning related to 50,743 Model 4000 syringe pumps.
If the devices don’t have the most recent software installed, the product might delay in its therapy administration, infusion could restart with incorrect parameters and doses can fall below the minimum recommended rate.
The FDA listed nine other potential issues:
- A high-priority alarm for delivery during motor not running
- Screen lock problems
- Interruptions in bolus or loading dose delivery
- Incorrect display of bolus/loading dose information
- Motor rate errors
- Incorrect recall of last settings
- Corrupt configurations
- Auto lock issues
- Problems with the toolbox configuration loading dose time values
Smiths Medical told its customers to confirm all pumps have the most recent Medfusion software installed. No devices have been recalled.
To date, Smiths Medical has received one injury report related to the Model 4000 pumps and another injury connected to the Model 3500.
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