Smiths Medical ASD Inc. has recalled approximately 109,608 Medfusion Syringe Pumps (Models 3500 and 4000) and replacement plunger parts due to a force sensor defect. A sensor in the device's occlusion detector can drift out of calibration, which may cause the pump to fail to detect blockages in the tubing or trigger false alarms. This issue is primarily found in devices manufactured before April 2022. Because these pumps are used to deliver critical medications, a failure to detect a blockage could result in a delay or interruption of life-saving therapy.
The sensor drift can lead to increased time to detect an occlusion (blockage), potentially resulting in an under-infusion of medication. Conversely, it can cause false occlusion alarms or system failure alarms that stop the pump, both of which can dangerously interrupt the delivery of medicine to the patient.
Manufacturer notification and device calibration awareness.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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