Infusion Pump False Alarms May Interrupt Necessary Therapy
Smiths Medical CADD-Solis VIP ambulatory infusion pumps may trigger false upstream occlusion alarms that interrupt patient therapy. Therapy interruption can cause serious injury or death.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This FDA Class I recall involves a critical medical device where false alarm failures can interrupt necessary infusion therapy, creating serious risk of patient injury or death as stated in the source.
Plain-English summary
Smiths Medical ASD, Inc. is recalling certain CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to a false alarm condition that can interrupt therapy.
The affected pumps may trigger an erroneous Upstream Occlusion Alarm under certain conditions. When this false alarm activates, it interrupts the active infusion without warning.
This recall affects approximately 185,975 units distributed in the US and 127,701 units outside the US. Therapy interruption or delay can lead to serious patient injury or death.
Patients and healthcare providers using these pumps should be aware of this Class I recall. Smiths Medical ASD, Inc. is the manufacturer responsible for providing information about corrective actions.
The recalled product
- Product
- CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-0
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- false-alarm
- therapy-interruption
Distribution
Distributed nationwide across the United States.
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