Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms
Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a medical device with potential for patient harm through delayed occlusion detection, but no reported illnesses or injuries. The hazard is theoretical and the recall is precautionary.
Plain-English summary
Smiths Medical ASD Inc. is recalling Medfusion Syringe Pump Model 3500VX-500, versions 3, 4, 5, and 6. All serial numbers of these model versions are affected.
A force sensor in the occlusion detector may drift out of calibration, particularly in devices manufactured before April 2022. This issue results from mechanical interference between components in the plunger head assembly. When the force sensor drifts out of calibration, the pump may display increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the calibration shift is large enough, the system displays diagnostic test failures such as Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test.
Although force sensor calibration shifts may occur in any device over time, Smiths Medical has identified an increased potential for such shifts in devices produced before April 2022. Out of an abundance of caution, the company is notifying all customers of this potential issue. Affected pumps were distributed nationwide in the United States and in Canada. Customers should contact Smiths Medical for guidance regarding their devices.
The recalled product
- Product
- Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- calibration-drift
- delayed-detection
- false-alarm
- system-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10610586032325
- All serial numbers
Distribution
Distributed nationwide across the United States.
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