ICU Medical is recalling 1,915 units of Plum Duo and Plum Solos infusion pumps because a software workflow issue can cause safety alerts to be bypassed. Internal testing discovered that software version 1.1.1 may allow clinicians to skip the 'Maximum Dose Limit' alert when setting up medications based on a patient's weight or body size. If this limit is bypassed, the pump could deliver more or less medication than intended. No injuries have been reported at this time.
The software defect allows the pump to bypass safety limits set in the hospital's drug library, potentially leading to incorrect medication dosages. This could result in serious patient harm or even death if critical medication is delivered outside of the prescribed safety parameters.
Quantity affected: 1,701 units. This device is an infusion pump.
Quantity affected: 214 units. This device is an infusion pump.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.