Smiths Medical is recalling 93,177 Medfusion Model 3500 Syringe pumps because several software issues can cause critical delivery errors, including the pump restarting with incorrect parameters or delivering medication while a high-priority alarm is active. These software defects, found in versions before v6.0.0, can result in patients receiving the wrong dose, an interrupted dose, or no dose at all. While these issues were corrected in software releases starting in 2012, many pumps still in use may not have been updated to the current version (v6.0.0 or later).
The software failures can cause the pump to display incorrect loading doses, experience screen locks, or fail to deliver medication as intended, which can lead to serious injury or death in clinical settings. These malfunctions disrupt the precise delivery of critical fluids and medications required for patient care.
You have 2 options:
Software Update
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.
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Sources: FDA iRES · Raw API Response
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