Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift
The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.
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: This is an FDA Class II recall of a medical device with documented risk of false alarms and delayed occlusion detection that could affect medication delivery accuracy. No illnesses or injuries have been reported; the recall is precautionary based on a potential hazard.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Medfusion Syringe Pump, Model 3500-500 (versions 3, 4, 5, and 6) due to a potential force sensor calibration issue in the occlusion detector. Approximately 20,815 units have been distributed worldwide, including throughout the United States and Canada.
A force sensor in the pump's occlusion detector may drift out of calibration over time. Depending on the magnitude of the drift, this can result in increased occlusion detection times, false occlusion alarms, or system failure alarms. The issue stems from mechanical interference between parts of the plunger head assembly in devices manufactured before April 2022.
If the calibration shift is large, the pump displays a System Failure Alarm. If the shift is smaller, the occlusion detection threshold may increase (delaying detection) or decrease (causing false alarms). Although sensor drift can occur naturally with any device over time, an increased potential for such shifts has been documented in the affected devices.
Smithes Medical ASD Inc. is recalling these pumps out of an abundance of caution to address this potential risk.
The recalled product
- Product
- Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- calibration-drift
- false-alarm
- delayed-detection
- 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 10610586032318
- All serial numbers
Distribution
Distributed nationwide across the United States.
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