CADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
Smiths Medical is recalling CADD-Solis VIP Ambulatory Infusion Pumps due to false Upstream Occlusion Alarms that may interrupt medication infusions, risking serious patient 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: The source explicitly states that interruption or delay of therapy can lead to serious patient injury or death. FDA has classified this as Class I. Per the rubric, the risk of death qualifies for a Critical (5) score.
Plain-English summary
Smiths Medical ASD, Inc. is recalling CADD-Solis VIP Ambulatory Infusion Pumps (multiple model numbers) due to a defect where the pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions.
When the false alarm occurs, it interrupts the active infusion of medication. Any interruption or delay of therapy can lead to serious patient injury or death, particularly for patients dependent on continuous infusions for critical conditions.
The pumps affected are distributed nationwide in the US and worldwide. Patients or healthcare providers using these pumps should contact Smiths Medical immediately for instructions on whether the pump should be discontinued or for guidance on next steps. Healthcare facilities should also review their inventory and patient usage records for affected model numbers.
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
- device-malfunction
Distribution
Distributed nationwide across the United States.
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