Baxter—PRISMAFLEX Control Units: Failure to Safely Unload Disposable Sets May Lead to Severe Blood Loss, with Potentially Fatal Outcome

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In a February 15, 2017, Urgent Device Correction letter submitted by an ECRI Institute member hospital, Baxter states that it has received reports of device operators failing to adhere to the instructions for use (IFU) pertaining to the safe unloading of disposable sets on the above units. These steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. Baxter also states that, if these instructions are not followed, severe blood loss may occur, with a potentially fatal outcome. Baxter further states that the above units are designed with specific features to ensure that device operators safely disconnect the patient before proceeding to unload the filter set after treatment. Specific instructions provided in the operator's manual and displayed onscreen require that,...